## Protocol Section
### Identification Module
**NCT ID:** NCT04066179

**Brief Title:** Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.

**Official Title:** Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients -A Randomized Controlled Trial.

#### Organization Study ID Info
**ID:** ILBS-AH-03
#### Organization
**Class:** OTHER
**Full Name:** Institute of Liver and Biliary Sciences, India
### Status Module
#### Completion Date
**Date:** 2021-02-27

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-09-09

**Type:** ACTUAL

**Last Update Submit Date:** 2019-09-05

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-02-27

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-09-07

**Type:** ESTIMATED

**Status Verified Date:** 2019-08

#### Study First Post Date
**Date:** 2019-08-26
**Type:** ACTUAL
**Study First Submit Date:** 2019-08-14
**Study First Submit QC Date:** 2019-08-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Institute of Liver and Biliary Sciences, India

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The patients of Severe Alcoholic Hepatitis (SAH) will be included in study based on inclusion and exclusion criteria. The patients will be then randomized in 3 groups for therapy. They will receive either steroid or Granulocyte-Colony Stimulating Factor (GCSF) or both. They will be followed for atleast 90 days for improvements in symptoms and various predefined parameters. Primary outcome will be improvement in survival at 90 Days. Patients will be monitored at every follow up for disease progression and complications of therapy. The study results will be analyzed for differences in survival rate and complications in different groups to propose new therapeutic guideline in SAH patients.

### Conditions Module

**Conditions:**

- Alcoholic Hepatitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 126

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days

**Intervention Names:**

- Drug: Gcsf

- Drug: Prednisolone

**Label:** Prednisolone+G-CSF

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Prednisolone 40 mg/day for 7 days

**Intervention Names:**

- Drug: Prednisolone

**Label:** Prednisolone

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days

**Intervention Names:**

- Drug: Gcsf

**Label:** Granulocytes-Colony Stimulating Factor

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Granulocytes-Colony Stimulating Factor

- Prednisolone+G-CSF

**Description:** Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days

**Name:** Gcsf

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Prednisolone

- Prednisolone+G-CSF

**Description:** Prednisolone 40 mg for initial 7 days

**Name:** Prednisolone

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** increase in Survival at 90 days in all the groups.

**Time Frame:** 90 days

#### Secondary Outcomes

**Description:** CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.

**Measure:** Improvement in CTP (Child-Pugh Score) in all the groups.

**Time Frame:** Day 28

**Description:** CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.

**Measure:** Improvement in CTP (Child-Pugh Score) in all the groups.

**Time Frame:** Day 180

**Description:** A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list. A MELD score is a number that ranges from 6 to 40, based on lab tests.

**Measure:** Improvement in MELD (Model for End Stage Liver Disease) in all the groups.

**Time Frame:** Day 28

**Description:** A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list. A MELD score is a number that ranges from 6 to 40, based on lab tests.

**Measure:** Improvement in MELD (Model for End Stage Liver Disease) in all the groups.

**Time Frame:** Day 180

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Severe alcoholic hepatitis patients \[Maddrey's score \> 32\] aged between 18 to 65 years.

Exclusion Criteria:

* Presence of active infections
* Acute Gastrointestinal bleed
* Hepatorenal syndrome
* Patient unwilling
* Discriminant Function \>90
* Autoimmune hepatitis
* Hepatitis B, Hepatitis C, Human immunodeficiency Virus cases
* Pregnancy
* Hemophagocytic lymphohistiocytosis (HLH)
* Hb\<8 and baseline White Blood Cell\>25000

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ajaymishrapandit@gmail.com

**Name:** Dr Ajay Mishra, MD

**Phone:** 01146300000

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New Delhi

**Contacts:**

***Contact 1:***

- **Email:** ajaymishrapandit@gmail.com

- **Name:** Dr Ajay Mishra, MD

- **Phone:** 01146300000

- **Role:** CONTACT

**Country:** India

**Facility:** Institute of Liver and Biliary Sciences

**State:** Delhi

**Status:** RECRUITING

**Zip:** 110070

### IPD Sharing Statement Module

**IPD Sharing:** NO

## 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: D000008108

- Term: Liver Diseases, Alcoholic

- ID: D000020751

- Term: Alcohol-Induced Disorders

- ID: D000019973

- Term: Alcohol-Related Disorders

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### 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: M9605

- Name: Hepatitis, Alcoholic

- Relevance: HIGH

- As Found: Alcoholic Hepatitis

- 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: M11108

- Name: Liver Diseases, Alcoholic

- Relevance: LOW

- As Found: Unknown

- ID: M22508

- Name: Alcohol-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21842

- Name: Alcohol-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006505

- Term: Hepatitis

- ID: D000006519

- Term: Hepatitis, Alcoholic

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M14120

- Name: Prednisolone

- Relevance: HIGH

- As Found: Vein

- ID: M1945

- Name: Lenograstim

- Relevance: LOW

- As Found: Unknown

- ID: M11749

- Name: Methylprednisolone

- Relevance: LOW

- As Found: Unknown

- ID: M1833

- Name: Methylprednisolone Acetate

- Relevance: LOW

- As Found: Unknown

- ID: M11750

- Name: Methylprednisolone Hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M229449

- Name: Prednisolone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M211887

- Name: Prednisolone hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M248881

- Name: Prednisolone phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000011239

- Term: Prednisolone

### Misc Info Module

- Version Holder: 2024-05-24
