Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)

NCT00709059 | Completed Results

• 1 other identifier: P04243
• Study Type: observational
• Target: 538
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.

Conditions

Hepatitis C, Chronic

Keywords

hepatitis C

Outcome Measures

Primary Outcomes (1)

• Number of Study Participants Who Had a Virological Response (VR) at Week-72

  VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test. Participants who dropped out or were withdrawn from treatment were considered not to respond.

  Treatment Week 72

Study Arms (1)

PegIntron Plus Rebetol

Previously untreated patients infected with HCV genotype 1, 4, 5, or 6.

Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908)

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031) BIOLOGICAL

PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks

Also known as: SCH 54031

PegIntron Plus Rebetol

Rebetol (ribavirin; SCH 18908) DRUG

Rebetol administered based on body weight 800-1200 mg/day (\<65 kg: 800 mg; 65 - 85 kg: 1000 mg; \>85 kg: 1200 mg) orally for 48 weeks

Also known as: SCH 18908

PegIntron Plus Rebetol

Eligibility Criteria

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

Study Population

Previously untreated patients with chronic hepatitis C, infected with HCV genotype 1, 4, 5, or 6, receiving treatment with PegIntron and Rebetol.

You may qualify if:

• Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol
• Detectable Hepatitis C Virus - Ribonucleic Acid (HCV-RNA) in serum by Polymerase Chain Reaction (PCR)
• Repeated (with at least a 1 month interval) serum transaminase (alanine aminotransferase \[ALT\]) levels above the upper normal limit for gender
• Documented chronic hepatitis C (CHC) of genotype 1/4/5/6

You may not qualify if:

• Known hypersensitivity for any active ingredient or constituent
• Pregnancy or lactation
• Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt
• Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months
• Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance \<50 mL/minute
• Hepatitis of immunologic origin or medically documented history of auto-immune disease
• Severe hepatic disorder or decompensated cirrhosis
• Pre-existing thyroid disorder, except if under control with classical treatment
• Epilepsy or central nervous system disorder
• Hemoglobin pathology, eg, thalassaemia, sickle cell anemia

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

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: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: July 3, 2008
• Study Start: December 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 4, 2015
• Results First Posted: January 10, 2011

Record last verified: 2015-11