Trials Sponsors Conditions Drugs Pricing

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 PegIntronDrug: Standard of Care Ribavirin

Interventions

Standard of Care PegIntronDrug

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 RibavirinDrug

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

Merck Sharp & Dohme LLC
Industrylead

Biospecimen

Retention: NONE RETAINED

Blood sample for polymerase chain reaction (PCR) Assay

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2bRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Results Point of Contact

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

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

2 participants (actual enrollment reported by the registry).

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 2009

Date type not reported

This date has not been verified as actual or estimated.

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)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Standard of Care PegIntron Plus Ribavirin [Part 2]

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Standard of Care PegIntron Plus Ribavirin [Part 2]

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record