## Protocol Section
### Identification Module
**NCT ID:** NCT00723879

**Brief Title:** Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206)

**Official Title:** Evaluation of Adherence Rate in Patients Receiving PegIntron / Rebetol (Weight Based) for Hepatitis C in Conjunction With a Patient Assistance Program.

#### Organization Study ID Info
**ID:** P04206
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
### Status Module
#### Completion Date
**Date:** 2008-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-11-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-11-02

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2008-07

**Type:** ACTUAL

#### Start Date
**Date:** 2004-10

**Status Verified Date:** 2015-11

#### Study First Post Date
**Date:** 2008-07-29
**Type:** ESTIMATED
**Study First Submit Date:** 2008-07-25
**Study First Submit QC Date:** 2008-07-25
**Why Stopped:** Because of slow recruitment; Despite the study was started long time ago (Oct 2004), we have not reached the projected number of patients (150 patients)
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.

### Conditions Module

**Conditions:**

- Hepatitis C, Chronic

- Hepacivirus

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 115

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients receiving a patient assistance program during therapy for hepatitis C will be enrolled into this study. All patients will receive PegIntron plus Rebetol (according to the label) and the patient assistance program.

**Intervention Names:**

- Biological: Peginterferon alfa-2b (SCH 54031)

- Drug: Ribavirin (SCH 18908)

- Behavioral: Patient assistance program

**Label:** Patients with hepatitis C

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients with hepatitis C

**Description:** Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

**Name:** Peginterferon alfa-2b (SCH 54031)

**Other Names:**

- PegIntron

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Patients with hepatitis C

**Description:** Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

**Name:** Ribavirin (SCH 18908)

**Other Names:**

- Rebetol

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Patients with hepatitis C

**Description:** Patient assistance programs will be classified as follows:

1. medications, including psychiatric medications (antidepressants);
2. other interventions, including nurse telephone calls and nurse support in the office: and
3. educational literature about hepatitis C containing information about the disease, mode of transmission, complications, and treatment and treatment drawbacks that will be given to each patient at the start of treatment.

**Name:** Patient assistance program

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Proportion of patients who complete treatment with PegIntron plus Rebetol therapy for hepatitis C when administered with a patient assistance program.

**Time Frame:** NA (i.e. the study was terminated)

**Measure:** Average length of treatment for patients receiving a patient assistance program as part of their treatment for hepatitis C with PegIntron plus Rebetol.

**Time Frame:** NA (i.e. the study was terminated)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with chronic hepatitis C naive to treatment

Exclusion Criteria:

* None

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature.

## 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: D000006521

- Term: Hepatitis, Chronic

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9611

- Name: Hepatitis C

- Relevance: HIGH

- As Found: Hepatitis C

- 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: M9607

- Name: Hepatitis, 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: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006526

- Term: Hepatitis C

- ID: D000019698

- Term: Hepatitis C, Chronic

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Ancestors

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M254669

- Name: Peginterferon alfa-2b

- Relevance: HIGH

- As Found: Detected

- ID: M15083

- Name: Ribavirin

- Relevance: HIGH

- As Found: Bevacizumab

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- 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: D000012254

- Term: Ribavirin

- ID: C000417083

- Term: Peginterferon alfa-2b

### Misc Info Module

- Version Holder: 2024-05-24
