Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)

Hepatitis C, Chronic Clinical Trial

Official title:

Evaluation of Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Patients With/Without Substitution Therapy in Austria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725751
• Other study ID #: P05255
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: October 1, 2015
• Start date: September 2007
• Est. completion date: March 2011

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Not applicable
• Study type: Observational

Clinical Trial Summary

Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with hepatitis C

Exclusion Criteria:

• According to the products' European labeling

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• Pegylated interferon alfa-2b (PegIFN-2b)
PegIFN-2b administered according to European labeling.

Drug:
• Ribavirin
Ribavirin administered according to European labeling.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin	For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.	24 to 48 weeks	No
Secondary	Number of Participants Who Achieved Sustained Virologic Response (SVR)	SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.	24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)	No
Secondary	Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy	This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.	Day 1	No