PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)

Liver Cirrhosis Clinical Trial

Official title:

PEG-Intron Plus REBETOL for the Treatment of Subjects With Chronic Hepatitis C Who Failed to Respond to Previous Combination Therapy (Any Alpha Interferon Treatment in Combination With Ribavirin)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039871
• Other study ID #: P02370
• Status: Completed
• Phase: Phase 3
• First received: June 13, 2002
• Last updated: March 26, 2015
• Start date: May 2002
• Est. completion date: September 2007

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2333
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age at entry 18-65

• Positive for Hepatitis C

• Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin

• Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis

Exclusion Criteria:

• Any cause for the liver disease other than chronic hepatitis C

• History or presence of complications of cirrhosis

• Alcohol or illicit drug use or methadone treatment within the past 2 years

• Treatment for chronic hepatitis C within the previous 6 months

• Diseases or conditions that could interfere with the subject's participation in and completion of the study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis

Intervention

Biological:
• PegIntron (peginterferon alfa-2b; SCH 54031)
PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks

Drug:
• REBETOL (ribavirin; SCH 18908)
REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Poynard T, Munteanu M, Colombo M, Bruix J, Schiff E, Terg R, Flamm S, Moreno-Otero R, Carrilho F, Schmidt W, Berg T, McGarrity T, Heathcote EJ, Gonçales F, Diago M, Craxi A, Silva M, Boparai N, Griffel L, Burroughs M, Brass C, Albrecht J. FibroTest is an — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virologic Response (SVR) Rate	Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)	Assessed at end of 24 weeks posttreatment follow-up	No
Secondary	Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12	Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up	24 weeks posttreatment	No
Secondary	Sustained Virologic Response (SVR) for Participants With Detectable But =2 Log Drop in HCV-RNA at Treatment Week 12	Number of participants with detectable HCV-RNA but =2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up	24 weeks posttreatment	No