NCT00709228

Brief Summary

To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
496

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2006

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 22, 2010

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

2.5 years

First QC Date

June 23, 2008

Results QC Date

November 9, 2009

Last Update Submit

January 14, 2015

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Number of HCV LVL G1 Participants Who Relapsed

    Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.

    Week 24 of follow-up

Study Arms (1)

PegIntron plus Rebetol

Those with chronic Hepatitis C infected with HCV LVL G1

Drug: PegIntronDrug: Rebetol

Interventions

PegIntronDRUG

1.5 ug/kg/week

Also known as: SCH 054031
PegIntron plus Rebetol
RebetolDRUG

800-1200 mg/day

Also known as: SCH 18908
PegIntron plus Rebetol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • Willingness to participate
  • years or older, either gender, any race
  • Must have Hepatitic C Virus Low Viral Load \[LCV LVL\] (positive, but \<600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction \[HCV-RNA/qPCR\] assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1
  • Subject considered suitable for treatment per local label
  • Investigator considers suitable and subject consents to be treated

You may not qualify if:

  • Does not show negative polymerase chain reaction \[PCR\] at week 4
  • Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
  • Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy \& lactation section of the Summary of Product Characteristics \[SmPC\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Craxi A, Koutsounas S, Ogurtsov P, Chemello L, Maticic M, Torras J, Diago M, Tartaglione MT, Witthoeft T, Yu X, Faruqi R, Chaudhri E, Pedicone LD, Zuckerman E. Peginterferon alfa-2b plus weight-based ribavirin for 24 weeks in patients with chronic hepatitis C virus genotype 1 with low viral load who achieve rapid viral response. J Viral Hepat. 2012 Feb;19(2):e120-5. doi: 10.1111/j.1365-2893.2011.01515.x. Epub 2011 Sep 19.

    PMID: 22239509RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for PCR

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)

RibonucleosidesNucleosidesNucleic 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

June 23, 2008

First Posted

July 3, 2008

Study Start

May 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

January 26, 2015

Results First Posted

February 22, 2010

Record last verified: 2015-01