## Protocol Section
### Identification Module
**NCT ID:** NCT06427395

**Brief Title:** Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

**Official Title:** A Multicenter, Open-Label, Extension Clinical Trial to Evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis (PBC)

#### Organization Study ID Info
**ID:** SARO.23.002
#### Organization
**Class:** INDUSTRY
**Full Name:** Zydus Therapeutics Inc.
### Status Module
#### Completion Date
**Date:** 2027-07-18

**Type:** ESTIMATED

#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-04-18

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Zydus Therapeutics Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

**Detailed Description:** A Multicenter, Open-Label, Extension Clinical trial to evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis (PBC)

### Conditions Module

**Conditions:**

- Primary Biliary Cholangitis

**Keywords:**

- Saroglitazar Magnesium

- Primary Biliary Cholangitis

- PBC

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Multicenter, Open-Label, phase III, safety and efficacy study

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Saroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 months).

**Intervention Names:**

- Drug: Saroglitazar Magnesium 1 mg

**Label:** Saroglitazar Magnesium 1 mg

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Saroglitazar Magnesium 1 mg

**Description:** Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in the open label extension program

**Name:** Saroglitazar Magnesium 1 mg

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

**Time Frame:** From baseline to 24 Months/EOT

#### Secondary Outcomes

**Description:** ALP \< 1.67 x ULN, ≥ 15% decrease in ALP, and total bilirubin ≤ ULN or direct bilirubin ≤ ULN relative to baseline in participants with known Gilbert's syndrome

**Measure:** Proportion of participants achieving biochemical response based on the composite endpoints of ALP and total bilirubin

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** complete normalization of ALP. Change and percent change from baseline in ALP

**Measure:** Proportion of participants with biochemical response based on the composite endpoints of ALP and total bilirubin

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Defined as new onset or recurrence of any of the following:

* Hospitalization for new onset or recurrence of variceal bleed
* Hepatic encephalopathy (as defined by a West Haven score ≥2)
* New onset ascites requiring treatment
* Refractory ascites (requiring large volume paracentesis)
* Spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)

**Measure:** Time to occurrence of the clinical outcome events in study participants with PBC

**Time Frame:** From baseline to 24 Months/EOT

**Description:** Time from enrolment to the first occurrence of Model for End Stage Liver Disease 3.0 score ≥ 15 and 25% increase from baseline as measured on 2 consecutive occasions performed at least two weeks apart with no competing etiologies identified

**Measure:** Time to occurrence of the clinical outcome events based on Model for End Stage Liver Disease 3.0 score

**Time Frame:** From baseline to 24 Months/EOT

**Measure:** Time to first occurrence of Liver transplant or placement on a liver transplant list

**Time Frame:** From baseline to 24 Months/EOT

**Description:** Death (liver and non-liver related)

**Measure:** Time to the occurrence of Death

**Time Frame:** From baseline to 24 Months/EOT

**Description:** Change from baseline in ALT

**Measure:** Effect on liver enzyme parameters

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in AST

**Measure:** Effect on liver enzyme parameters

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in GGT

**Measure:** Effect on liver enzyme parameters

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in total bilirubin

**Measure:** Effect on liver enzyme parameters

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in TG

**Measure:** Effect on lipid parameters

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in LDL-C

**Measure:** Effect on lipid parameters

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in HDL-C

**Measure:** Effect on lipid parameters

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in VLDL-C

**Measure:** Effect on lipid parameters

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in total cholesterol

**Measure:** Effect on lipid parameters

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in non-HDL-C

**Measure:** Effect on lipid parameters

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in serum bile acids

**Measure:** Effect on liver enzyme parameters

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in quality of life (PBC 40) questionnaire domains

**Measure:** Effect on disease-related symptoms

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in 5-D itch scale

**Measure:** Effect on disease-related symptoms

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in Worst Itch NRS scores

**Measure:** Effect on disease-related symptoms

**Time Frame:** From baseline to Months 12 and 24/EOT

**Description:** Change from baseline in LSM assessed by Liver elastography/FibroScan

**Measure:** Effect on liver stiffness measurement (LSM) assessed by Liver elastography/FibroScan

**Time Frame:** From baseline to Months 12 and 24/EOT

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Must provide written informed consent and agree to comply with the trial protocol
2. Participated and completed SARO.21.001, the double-blind treatment phase study

Exclusion Criteria:

1. Consumption of 2 standard drinks per day if male and 1 standard drink per day if female for 3 consecutive months (12 consecutive weeks) throughout double-blind phase till screening.
2. Participants with MELD 3.0 score of 15 or greater
3. History or presence of other concomitant liver diseases at screening:

   1. Chronic hepatitis B or C virus (HBV, HCV) infection
   2. Primary sclerosing cholangitis (PSC)
   3. Alcoholic liver disease
   4. Autoimmune hepatitis (AIH)-PBC overlap syndrome
   5. Hemochromatosis
   6. Non-alcoholic steatohepatitis (NASH) on historical biopsy
4. Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, uncontrolled ascites, encephalopathy, history of variceal bleeding or history of hepatorenal syndrome at screening.
5. Use of Thiazolidinediones or Fibrates (within 12 weeks prior to screening)
6. Use of Obeticholic acid (OCA), methotrexate, budesonide and other systemic corticosteroids (Prednisone dose more than 10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening)
7. History of bowel surgery (gastrointestinal \[bariatric\] surgery in the preceding 1 year or undergoing evaluation for gastrointestinal surgery (bariatric surgery for obesity, extensive small-bowel resection) or orthotopic liver transplant (OLT) or listed for OLT
8. Unstable cardiovascular disease, including:

   1. Unstable angina, (i.e., new or worsening symptoms of coronary heart disease in the 12 weeks before screening and throughout the screening period), acute coronary syndrome in the 24 weeks before screening and throughout the screening period, acute myocardial infarction in the 12 weeks before screening and throughout the screening period or heart failure of New York Heart Association class (III - IV) or worsening congestive heart failure, or coronary artery intervention, in the 24 weeks before screening and throughout the screening period
   2. History/current unstable cardiac dysrhythmias
   3. Uncontrolled hypertension at screening
   4. Stroke or transient ischemic attack in the 24 weeks before screening
9. History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, and coagulation disorders
10. An uncontrolled thyroid disorder

    1. Uncontrolled hyperthyroidism: defined as any history of hyperthyroidism that has either not been treated with either radioactive iodine and/or surgery or that has been treated with radioactive iodine and/or surgery, but has required ongoing continuous or intermittent use of thyroid hormone synthesis inhibitors (i.e., methimazole or propylthiouracil) in the 24 weeks before screening
    2. Uncontrolled hypothyroidism: defined as initiation of thyroid hormone replacement therapy or dose adjustment of replacement therapy in the 12 weeks before screening
11. History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 × ULN at screening
12. Any of the following laboratory values:

    1. Total bilirubin \> 3 x ULN
    2. Platelets \< 50 × 103/mL
    3. Albumin \< 2.8 g/dL
    4. eGFR \< 45 mL/min/1.73 m2
    5. ALT or AST \> 250 U/L x ULN
    6. ALP \> 10 × ULN
13. Participation in another interventional clinical study and receipt of any other investigational medication or medical device within 30 days or within 5 half-lives, whatever is longer, prior to screening
14. History of malignancy in the past 5 years and/or active neoplasm which may diminish life expectancy (except resolved superficial non-melanoma skin cancer, carcinomas in situ or other stable, relatively benign conditions if appropriately treated prior to screening)
15. Known allergy, sensitivity or intolerance to the study medication or formulation ingredients
16. Pregnancy-related exclusions, including:

    1. Pregnant/lactating female (including positive pregnancy test at screening)
    2. Participants agree to avoid pregnancy either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study medication. Refer Appendix 9 Contraceptive Guidance.
17. History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption)
18. Cirrhosis with Child-Pugh-Turcotte (CPT) class B or C having score of 7 or above at screening (Refer Appendix 11

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** fshaikh@zydustherapeutics.com

**Name:** Farheen Shaikh

**Phone:** 609-730-1900

**Phone Ext:** 221

**Role:** CONTACT

**Contact 2:**

**Email:** dparmar@zydustherapeutics.com

**Name:** Deven Parmar

**Phone:** 609-559-0765

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Birmingham

**Contacts:**

***Contact 1:***

- **Name:** Haley Sanford

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US007

**State:** Alabama

**Zip:** 35294

**Location 2:**

**City:** Los Angeles

**Contacts:**

***Contact 1:***

- **Name:** Nirosha Tilakaratna

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US013

**State:** California

**Zip:** 90048

**Location 3:**

**City:** Pasadena

**Contacts:**

***Contact 1:***

- **Name:** Ariadne Cabrera

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US011

**State:** California

**Zip:** 91105

**Location 4:**

**City:** Sacramento

**Contacts:**

***Contact 1:***

- **Name:** Jerica Golez

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US043

**State:** California

**Zip:** 95817

**Location 5:**

**City:** Aurora

**Contacts:**

***Contact 1:***

- **Name:** Allison Kuehn

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US022

**State:** Colorado

**Zip:** 80045

**Location 6:**

**City:** New Haven

**Contacts:**

***Contact 1:***

- **Name:** Suzie Christopher

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US037

**State:** Connecticut

**Zip:** 06520

**Location 7:**

**City:** Jacksonville

**Contacts:**

***Contact 1:***

- **Name:** Reagan Dukes

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US027

**State:** Florida

**Zip:** 32082

**Location 8:**

**City:** Lakewood Ranch

**Contacts:**

***Contact 1:***

- **Name:** Mandy Burdine

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US006

**State:** Florida

**Zip:** 34211

**Location 9:**

**City:** Miami

**Contacts:**

***Contact 1:***

- **Name:** Kenia Moreno

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US005

**State:** Florida

**Zip:** 33136

**Location 10:**

**City:** Marietta

**Contacts:**

***Contact 1:***

- **Name:** Lynn Bauch

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US020

**State:** Georgia

**Zip:** 30060

**Location 11:**

**City:** Indianapolis

**Contacts:**

***Contact 1:***

- **Name:** Mandy Cruz

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US001

**State:** Indiana

**Zip:** 46202

**Location 12:**

**City:** Rochester

**Contacts:**

***Contact 1:***

- **Name:** Mitch Clayton

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US023

**State:** Minnesota

**Zip:** 55905

**Location 13:**

**City:** Saint Louis

**Contacts:**

***Contact 1:***

- **Name:** Andrea Riemenschneider

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US030

**State:** Missouri

**Zip:** 63104

**Location 14:**

**City:** Omaha

**Contacts:**

***Contact 1:***

- **Name:** Carol Carney

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US024

**State:** Nebraska

**Zip:** 68198

**Location 15:**

**City:** Rochester

**Contacts:**

***Contact 1:***

- **Name:** Chelsea DiBella

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US035

**State:** New York

**Zip:** 14642

**Location 16:**

**City:** Charlotte

**Contacts:**

***Contact 1:***

- **Name:** Marina Sycheva

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US002

**State:** North Carolina

**Zip:** 28204

**Location 17:**

**City:** Cincinnati

**Contacts:**

***Contact 1:***

- **Name:** Lori Ankney

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US014

**State:** Ohio

**Zip:** 55905

**Location 18:**

**City:** Philadelphia

**Contacts:**

***Contact 1:***

- **Name:** Stacey Carmody

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US015

**State:** Pennsylvania

**Zip:** 19141

**Location 19:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Name:** Sali Albarouk

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US004

**State:** Texas

**Zip:** 77030

**Location 20:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Name:** DeShara Emerson

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US042

**State:** Texas

**Zip:** 77030

**Location 21:**

**City:** Murray

**Contacts:**

***Contact 1:***

- **Name:** Anika Unsworth

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US031

**State:** Utah

**Zip:** 84107

**Location 22:**

**City:** Charlottesville

**Contacts:**

***Contact 1:***

- **Name:** Holly McComb

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US016

**State:** Virginia

**Zip:** 22908

**Location 23:**

**City:** Richmond

**Contacts:**

***Contact 1:***

- **Name:** Caitlin Hurst

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US039

**State:** Virginia

**Zip:** 23219

**Location 24:**

**City:** Seattle

**Contacts:**

***Contact 1:***

- **Name:** Teresa Collins

- **Role:** CONTACT

**Country:** United States

**Facility:** Zydus US033

**State:** Washington

**Zip:** 98105

**Location 25:**

**City:** Ciudad Autónoma de Buenos Aires

**Contacts:**

***Contact 1:***

- **Name:** Ignacio Lucero

- **Role:** CONTACT

**Country:** Argentina

**Facility:** Zydus AR007

**State:** Buenos Aires

**Zip:** 1199

**Location 26:**

**City:** Ciudad Autónoma de Buenos Aires

**Contacts:**

***Contact 1:***

- **Name:** Karina Barroso

- **Role:** CONTACT

**Country:** Argentina

**Facility:** Zydus AR006

**State:** Buenos Aires

**Zip:** 1405

**Location 27:**

**City:** Ciudad Autónoma de Buenos Aires

**Contacts:**

***Contact 1:***

- **Name:** Ailén Sparnocchia

- **Role:** CONTACT

**Country:** Argentina

**Facility:** Zydus AR001

**State:** Buenos Aires

**Zip:** 1640

**Location 28:**

**City:** Ciudad Autónoma de Buenos Aires

**Contacts:**

***Contact 1:***

- **Name:** Verónica Martinez

- **Role:** CONTACT

**Country:** Argentina

**Facility:** Zydus AR005

**State:** Buenos Aires

**Zip:** 2345

**Location 29:**

**City:** Ciudad Autónoma de Buenos Aires

**Contacts:**

***Contact 1:***

- **Name:** Belen Umina

- **Role:** CONTACT

**Country:** Argentina

**Facility:** Zydus AR003

**State:** Buenos Aires

**Zip:** 4693

**Location 30:**

**City:** Mar del Plata

**Contacts:**

***Contact 1:***

- **Name:** Ariana Balcarce

- **Role:** CONTACT

**Country:** Argentina

**Facility:** Zydus AR009

**State:** Buenos Aires

**Zip:** 7600

**Location 31:**

**City:** Pilar

**Contacts:**

***Contact 1:***

- **Name:** Gabriela Marinsalta

- **Role:** CONTACT

**Country:** Argentina

**Facility:** Zydus AR004

**State:** Buenos Aires

**Zip:** 1500

**Location 32:**

**City:** Rosario

**Contacts:**

***Contact 1:***

- **Name:** Gabriela Juaristi

- **Role:** CONTACT

**Country:** Argentina

**Facility:** Zydus AR010

**State:** Santa Fe

**Zip:** 2000

**Location 33:**

**City:** Adana

**Contacts:**

***Contact 1:***

- **Name:** Asya Cıblakbas

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR014

**Zip:** 236

**Location 34:**

**City:** Altındag

**Contacts:**

***Contact 1:***

- **Name:** Müge Demirsu

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR016

**Location 35:**

**City:** Ankara

**Contacts:**

***Contact 1:***

- **Name:** Pınar Anul

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR004

**Zip:** 1604

**Location 36:**

**City:** Bursa

**Contacts:**

***Contact 1:***

- **Name:** Merve Karatas

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR005

**Zip:** 16059

**Location 37:**

**City:** Cebeci

**Contacts:**

***Contact 1:***

- **Name:** Melike Zeynep Ciftci

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR017

**Location 38:**

**City:** Gaziantep

**Contacts:**

***Contact 1:***

- **Name:** Selin Büdeyri Sayın

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR008

**Zip:** 27080

**Location 39:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Name:** Aybüke Mutaflar Peksert

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR009

**Zip:** 34093

**Location 40:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Name:** Sevval Ceren Asi

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR001

**Zip:** 34899

**Location 41:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Name:** Kubra Karacaoglu

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR003

**Zip:** 36764

**Location 42:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Name:** Aybüke Mutaflar Peksert

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR010

**Location 43:**

**City:** Izmir

**Contacts:**

***Contact 1:***

- **Name:** Gizem Gunyer

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR002

**Zip:** 06230

**Location 44:**

**City:** Izmir

**Contacts:**

***Contact 1:***

- **Name:** Buket Uzun

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR013

**Location 45:**

**City:** Kocaeli

**Contacts:**

***Contact 1:***

- **Name:** Dunya Avcilar

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR011

**Zip:** 41110

**Location 46:**

**City:** Melikgazi

**Contacts:**

***Contact 1:***

- **Name:** Banu Çiçek Yakışan

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR015

**Location 47:**

**City:** Mersin

**Contacts:**

***Contact 1:***

- **Name:** Didem Balci

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Zydus TR006

**Zip:** 33079

#### Overall Officials

**Official 1:**

**Affiliation:** Zydus Therapeutics Inc.

**Name:** Deven Parmar

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001649

- Term: Bile Duct Diseases

- ID: D000001660

- Term: Biliary Tract Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000002780

- Term: Cholestasis, Intrahepatic

- ID: D000002779

- Term: Cholestasis

- ID: D000008107

- Term: Liver Diseases

- ID: D000008103

- Term: Liver Cirrhosis

- ID: D000005355

- Term: Fibrosis

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6002

- Name: Cholangitis

- Relevance: HIGH

- As Found: Cholangitis

- ID: M11103

- Name: Liver Cirrhosis

- Relevance: LOW

- As Found: Unknown

- ID: M11105

- Name: Liver Cirrhosis, Biliary

- Relevance: HIGH

- As Found: Primary Biliary Cholangitis

- ID: M4935

- Name: Bile Duct Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4946

- Name: Biliary Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6019

- Name: Cholestasis

- Relevance: LOW

- As Found: Unknown

- ID: M6020

- Name: Cholestasis, Intrahepatic

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8485

- Name: Fibrosis

- Relevance: LOW

- As Found: Unknown

- ID: T4683

- Name: Primary Biliary Cholangitis

- Relevance: HIGH

- As Found: Primary Biliary Cholangitis

### Condition Browse Module - Meshes

- ID: D000002761

- Term: Cholangitis

- ID: D000008105

- Term: Liver Cirrhosis, Biliary

### Misc Info Module

- Version Holder: 2024-05-31
