NCT01258101

Brief Summary

This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
395

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2003

Longer than P75 for phase_4

Geographic Reach
1 country

18 active sites

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, 2003

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 10, 2010

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

July 11, 2016

Completed
Last Updated

July 11, 2016

Status Verified

May 1, 2016

Enrollment Period

5.2 years

First QC Date

November 29, 2010

Results QC Date

January 5, 2016

Last Update Submit

May 30, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment

    Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment.

    Up to Week 48 (24 weeks post completion of the treatment)

  • Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48

    Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively.

    At Week 24 and Week 48

Secondary Outcomes (9)

  • Percentage of Participants With Virological Response at the End of the Treatment

    At Week 16 and Week 24

  • Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment

    At Week 16 and Week 24

  • Number of Participants With Any Adverse Events and Any Serious Adverse Events

    Up to Week 48

  • Median Hemoglobin Levels at End of Treatment

    At Week 16 and Week 24

  • Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48

    At Baseline (Week 0) and Weeks 16, 24 and 48

  • +4 more secondary outcomes

Study Arms (4)

Peginterferon/Ribavirin 800 mg (24 Weeks)

EXPERIMENTAL

Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W).

Drug: peginterferon alfa-2a [Pegasys]Drug: ribavirin

Peginterferon/Ribavirin 400 mg (24 Weeks)

EXPERIMENTAL

Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W.

Drug: peginterferon alfa-2a [Pegasys]Drug: ribavirin

Peginterferon/Ribavirin 800 mg (16 Weeks)

EXPERIMENTAL

Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W.

Drug: peginterferon alfa-2a [Pegasys]Drug: ribavirin

Peginterferon/Ribavirin 400 mg (16 Weeks)

EXPERIMENTAL

Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 16 W.

Drug: peginterferon alfa-2a [Pegasys]Drug: ribavirin

Interventions

peginterferon alfa-2a [Pegasys]DRUG

180 mcg sc weekly, 24 weeks

Peginterferon/Ribavirin 400 mg (24 Weeks)Peginterferon/Ribavirin 800 mg (24 Weeks)
ribavirinDRUG

800 mg orally daily

Peginterferon/Ribavirin 800 mg (16 Weeks)Peginterferon/Ribavirin 800 mg (24 Weeks)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients, 18-65 years of age
  • Chronic hepatitis C, genotype 2 or 3
  • Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)
  • Abdominal sonography within 3 months prior to study start

You may not qualify if:

  • Previous interferon and/or pegylated interferon and ribavirin therapy
  • Liver cirrhosis, class B or C (Child-Pugh)
  • Systemic anti-neoplastic or immunomodulatory treatment \<=6 months before study drug
  • History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C
  • Decompensated liver disease
  • Positive for HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Gratwein, 8112, Austria

Location

Unknown Facility

Graz, 8036, Austria

Location

Unknown Facility

Innsbruck, 6020, Austria

Location

Unknown Facility

Linz, 4010, Austria

Location

Unknown Facility

Linz, 4020, Austria

Location

Unknown Facility

Oberndorf, 5110, Austria

Location

Unknown Facility

Ried-innkreis, 4910, Austria

Location

Unknown Facility

Salzburg, 5020, Austria

Location

Unknown Facility

Vienna, 1030, Austria

Location

Unknown Facility

Vienna, 1090, Austria

Location

Unknown Facility

Vienna, 1100, Austria

Location

Unknown Facility

Vienna, 1130, Austria

Location

Unknown Facility

Vienna, 1140, Austria

Location

Unknown Facility

Vienna, 1160, Austria

Location

Unknown Facility

Vienna, 1220, Austria

Location

Unknown Facility

Villach, 9500, Austria

Location

Unknown Facility

Wels, 4600, Austria

Location

Unknown Facility

Wiener Neustadt, 2700, Austria

Location

Related Publications (1)

  • Maieron A, Metz-Gercek S, Scherzer TM, Laferl H, Fischer G, Bischof M, Gschwantler M, Ferenci P. Shortening of treatment duration in patients with chronic hepatitis C genotype 2 and 3 - impact of ribavirin dose - a randomized multicentre trial. BMC Res Notes. 2011 Jun 29;4:220. doi: 10.1186/1756-0500-4-220.

    PMID: 21714878DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 616878333

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2010

First Posted

December 10, 2010

Study Start

May 1, 2003

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 11, 2016

Results First Posted

July 11, 2016

Record last verified: 2016-05

Locations

AU(18)