## Protocol Section
### Identification Module
**NCT ID:** NCT03063879

**Acronym:** SD-CRF

**Brief Title:** Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

**Official Title:** Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.

#### Organization Study ID Info
**ID:** 96-04-37-37348
#### Organization
**Class:** OTHER
**Full Name:** Tehran University of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2019-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-09-30

**Type:** ACTUAL

**Last Update Submit Date:** 2019-09-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-09-01

**Type:** ACTUAL

#### Start Date
**Date:** 2017-04-01

**Type:** ACTUAL

**Status Verified Date:** 2018-02

#### Study First Post Date
**Date:** 2017-02-24
**Type:** ACTUAL
**Study First Submit Date:** 2017-02-21
**Study First Submit QC Date:** 2017-02-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Ahvaz Jundishapur University of Medical Sciences

**Class:** OTHER

**Name:** Shiraz University of Medical Sciences

**Class:** OTHER

**Name:** Hamadan University of Medical Science

#### Lead Sponsor

**Class:** OTHER

**Name:** Tehran University of Medical Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although no particular adverse event has been linked to this metabolite sofosbuvir is not recommended for patients with renal failure mainly because of lack of data. Nevertheless there are anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir and daclatasvir in treating hepatitis C in 100 patients with renal failure.

### Conditions Module

**Conditions:**

- Hepatitis C, Chronic

- Chronic Renal Failure

**Keywords:**

- hepatitis C

- renal failure

- sofosbuvir

- daclatasvir

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 95

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Sofosbuvir 400 mg and daclatasvir 60 mg

**Intervention Names:**

- Drug: Sofosbuvir 400 mg and daclatasvir 60 mg

**Label:** Sovodak

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sovodak

**Description:** Daily fixed dose combination pill (Sovodak) containing 400 mg sofosbuvir and 60 mg daclatasvir for 12 weeks if not cirrhotic (liver stiffness \< 12 KPa) or 24 weeks if cirrhotic

**Name:** Sofosbuvir 400 mg and daclatasvir 60 mg

**Other Names:**

- Sovodak

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment

**Measure:** Sustained Viral Response (SVR12)

**Time Frame:** 12 weeks after end of treatment

#### Secondary Outcomes

**Description:** Adverse drug events recorded by direct questioning

**Measure:** Safety as assessed by adverse drug events

**Time Frame:** From start of treatment to 12 weeks after end of treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
* Renal failure (eGFR \< 30 cc/min) or under hemodialysis

Exclusion Criteria:

* Model for End-stage Liver Disease (MELD) score \> 20,
* Child's C (CTP score \> 12),
* Heart rate \< 50/min,
* Taking amiodarone

**Maximum Age:** 75 Years

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tehran

**Country:** Iran, Islamic Republic of

**Facility:** Shariati Hospital

**Zip:** 14117

#### Overall Officials

**Official 1:**

**Affiliation:** Tehran University of Medical Sciences

**Name:** Shahin Merat, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Poustchi H, Majd Jabbari S, Merat S, Sharifi AH, Shayesteh AA, Shayesteh E, Minakari M, Fattahi MR, Moini M, Roozbeh F, Mansour-Ghanaei F, Afshar B, Mokhtare M, Amiriani T, Sofian M, Somi MH, Agah S, Maleki I, Latifnia M, Fattahi Abdizadeh M, Hormati A, Khoshnia M, Sohrabi M, Malekzadeh Z, Merat D, Malekzadeh R. The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment. J Gastroenterol Hepatol. 2020 Sep;35(9):1590-1594. doi: 10.1111/jgh.14994. Epub 2020 Feb 5.

**PMID:** 31994788

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018178

- Term: Flaviviridae Infections

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000006521

- Term: Hepatitis, Chronic

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: HIGH

- As Found: Chronic Renal Failure

- ID: M9611

- Name: Hepatitis C

- Relevance: HIGH

- As Found: Hepatitis C

- ID: M26718

- Name: Renal Insufficiency

- Relevance: HIGH

- As Found: Renal Failure

- ID: M21613

- Name: Hepatitis C, Chronic

- Relevance: HIGH

- As Found: Hepatitis C, Chronic

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20324

- Name: Flaviviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M9607

- Name: Hepatitis, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006526

- Term: Hepatitis C

- ID: D000019698

- Term: Hepatitis C, Chronic

- ID: D000006505

- Term: Hepatitis

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000007676

- Term: Kidney Failure, Chronic

### Intervention Browse Module - Ancestors

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M443

- Name: Sofosbuvir

- Relevance: HIGH

- As Found: Chronic Pain

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069474

- Term: Sofosbuvir

### Misc Info Module

- Version Holder: 2024-05-24
