NCT00475072

Brief Summary

This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in male patients with hemophilia A and chronic hepatitis C. All patients will receive PEGASYS 180 micrograms s.c. weekly plus ribavirin 1000-1200mg p.o. daily (depending on body weight) for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2007

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

3.1 years

First QC Date

May 16, 2007

Last Update Submit

October 29, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • SVR

    Week 72

Secondary Outcomes (1)

  • AEs, laboratory parameters.

    Throughout study

Study Arms (1)

1

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

Interventions

peginterferon alfa-2a [Pegasys]DRUG

180 micrograms sc weekly for 48 weeks

1
ribavirinDRUG

1000/1200mg po daily for 48 weeks

1

Eligibility Criteria

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

You may qualify if:

  • male patients, \>=18 years of age;
  • hemophilia A;
  • chronic hepatitis C;
  • compensated liver disease.

You may not qualify if:

  • therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment \<=6 months before start of study drug;
  • hepatitis A, hepatitis B or HIV infection;
  • chronic liver disease other than chronic hepatitis C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Mexico City, 02990, Mexico

Location

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

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 16, 2007

First Posted

May 17, 2007

Study Start

June 1, 2003

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

ME(1)