Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)

NCT00255008 | Terminated Phase 4 Results

• 1 other identifier: P04212
• Study Type: interventional
• Target: 121
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian patients with genotype 1 chronic hepatitis C. This study is also designed to provide a randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at 24 weeks after therapy completion.

Conditions

Hepatitis C, Chronic

Keywords

chronic hepatitis C; pegylated interferon alfa-2b; ribavirin; Asia

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Achieved a Sustained Virologic Response (SVR)

  SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed.

  24 weeks after completion of either up to 24 or 48 weeks of therapy

Study Arms (4)

Genotype 1 SEA PEG-IFN/RIB 48 w

ACTIVE COMPARATOR

Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PEG-Intron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy

Biological: peginterferon alfa-2b; Drug: ribavirin

Genotype 1 Caucasian PEG-IFN/RIB 48 w

ACTIVE COMPARATOR

Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy

Biological: peginterferon alfa-2b; Drug: ribavirin

Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w

EXPERIMENTAL

Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy

Biological: peginterferon alfa-2b; Drug: ribavirin

Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w

ACTIVE COMPARATOR

Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy

Biological: peginterferon alfa-2b; Drug: ribavirin

Interventions

peginterferon alfa-2b BIOLOGICAL

Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks

Also known as: SCH 54031, PegIntron REDIPEN

Genotype 1 Caucasian PEG-IFN/RIB 48 w; Genotype 1 SEA PEG-IFN/RIB 48 w; Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w

ribavirin DRUG

200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks

Also known as: SCH 18908, REBETOL

Genotype 1 Caucasian PEG-IFN/RIB 48 w; Genotype 1 SEA PEG-IFN/RIB 48 w; Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Comply with all current Australian Schedule of Pharmaceutical Benefits S100 eligibility criteria.
• Able to give written informed consent and adhere to study visit schedule.
• South East Asian ethnicity (except for Caucasian Gt1/1b in comparator arm) i.e. born in Vietnam, Cambodia, Laos, Thailand, Hong Kong, and China or have both parents born in these countries.
• Genotype 1, 1a, 1b, 6, 6a, 6b, 7, 8, or 9, as classified by INNO-LiPA assay.
• Hemoglobin \>=120 g/L (females), \>=130 g/L (males).
• Platelet count \>=100 x 10\^9/L.
• Neutrophil count \>=1.5 x 10\^9/L.
• Negative pregnancy test for females.
• Thyroid stimulating hormone (TSH) within normal limits.

You may not qualify if:

• Participation in any other investigational drug program within 30 days of the Screening Visit.
• Human immunodeficiency virus (HIV) antibody positive or hepatitis B surface antigen (HBsAg) positive.
• Genotype 2, 3, 4, or 5, as classified by INNO-LiPA assay.
• Non South East Asian ethnicity (unless recruited to Caucasian GT1 comparator arm).
• Evidence of liver disease due to other disorders (e.g., hemachromatosis, Wilson's disease).
• Ongoing drug or alcohol abuse which in the opinion of the investigator would jeopardize the patient's ability to comply with study requirements.
• Inability to comply with study requirements for other reasons.
• Decompensated cirrhosis (Ascites, history of encephalopathy or bleeding varices, serum albumin \<35 g/L, prothrombin time (PT) prolonged by greater than 3 sec).
• Present or prior history of severe psychiatric disease requiring hospitalization or medication.
• History of severe seizure disorder.
• History of autoimmune disorders (e.g., rheumatoid arthritis, inflammatory bowel disease, immune thrombocytopenic purpura, systemic lupus erythematosus, or other mixed connective tissue disease, psoriasis, optic neuritis).
• Poorly controlled thyroid disease.
• Creatinine clearance \<50 mL/min.
• Severe cardiovascular disease.
• Hepatocellular cancer.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck, Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 17, 2005
• Study Start: March 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 6, 2017
• Results First Posted: January 6, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share