Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2)

NCT01054742 | Completed Results

• 1 other identifier: P04793 Part 2
• Study Type: observational
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this observational study was to provide summary data from participants who relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care PegIntron plus ribavirin in Part 1 of the study (NCT00709228) and who then received retreatment during Part 2 of the study. Relapse was defined as having a positive virology result at the Week 24 post-treatment follow-up, after a negative result at the Week 24 end-of-treatment time point. Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels were measured at Day 1 and Weeks 12, 24, and 48 of the extension, and at Follow-up Week 24.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study

  A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA.

  From Day 1, Week 1 [Part 2 ] through Follow-up Week 24 [ Part 2]

Study Arms (1)

Standard of Care PegIntron Plus Ribavirin [Part 2]

Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribavirin for 48 weeks.

Drug: Standard of Care PegIntron; Drug: Standard of Care Ribavirin

Interventions

Standard of Care PegIntron DRUG

Commercially available PegIntron administered subcutaneously (SC) at 1.5 μg/kg weekly in accordance with the PegIntron Summary of Product Characteristics (SmPC).

Also known as: peginterferon alfa-2b, PEG2b, SCH 054031

Standard of Care PegIntron Plus Ribavirin [Part 2]

Standard of Care Ribavirin DRUG

Commercially available ribavirin administered orally at 800-1200 mg/day based on body weight in accordance with the ribavirin SmPC.

Also known as: REBETOL;, SCH 018908

Standard of Care PegIntron Plus Ribavirin [Part 2]

Eligibility Criteria

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

Study Population

Only participants who were originally treated in study P04793 and relapsed during the 24 week follow up phase were offered the chance to receive retreatment with PegIntron and ribavirin for up to an additional 48 weeks.

You may qualify if:

• Willingness to participate
• years or older, either gender, any race
• Participant has relapsed at the end of the Part 1 follow-up phase (defined as having a positive virology result at 24 weeks of follow-up post treatment after a negative result at the Week 24 end-of-treatment time point)
• Participant considered suitable for treatment per local label
• Investigator considers suitable and participant consents to be treated

You may not qualify if:

• Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
• Participant does not qualify based on contra-indication, special warning, special population, and/or pregnancy \& lactation section of the SmPC

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Biospecimen

Retention: NONE RETAINED

Blood sample for polymerase chain reaction (PCR) Assay

MeSH Terms

Conditions

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; Liver Diseases; Digestive System Diseases

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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 22, 2010
• Study Start: December 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 16, 2015
• Results First Posted: August 22, 2012

Record last verified: 2015-01