NCT00308048

Brief Summary

Patients with HCV genotype 2 or 3 infection who have a rapid virological response to treatment are randomised to either 14 or 24 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
435

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2004

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

July 6, 2011

Status Verified

March 1, 2006

First QC Date

March 27, 2006

Last Update Submit

July 3, 2011

Conditions

Hepatitis C Virus Infection

Keywords

InterferonPegylated interferonPegylated interferon alfa 2bHepatitis CGenotype 2Genotype 3Rapid virological responseShort treatment14 weeks treatmenthealth related quality of lifesick leaveInjecting drug use

Outcome Measures

Primary Outcomes (1)

  • Sustained virological response (SVR) =HCV RNA negativity (<20 IU/ml) six months after end of treatment.

Secondary Outcomes (2)

  • Change in health related quality as measured by short from 36 (SF-36) from baseline to 6 months after end of treatment.

  • Sick leave in patients treated for 14 or 24 weeks treatment

Interventions

Pegylated Interferon alfa 2b and ribavirinDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCV RNA positive Genotype 2 or 3 Treatment naive Raised ALT

You may not qualify if:

  • Active substance abuse Poorly controlled psychiatric disease Decompensated cirrhosis HBsAg positive Anti-HIV positive Suffering from other significant concurrent medical conditions including chronic liver diseases -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevaal University Hospital

Oslo, 0407, Norway

Location

Related Publications (1)

  • Dalgard O, Bjoro K, Hellum KB, Myrvang B, Ritland S, Skaug K, Raknerud N, Bell H. Treatment with pegylated interferon and ribavarin in HCV infection with genotype 2 or 3 for 14 weeks: a pilot study. Hepatology. 2004 Dec;40(6):1260-5. doi: 10.1002/hep.20467.

    PMID: 15558712BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Olav Dalgard, MD PhD

    Ullevaal University Hospital, Oslo, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 28, 2006

Study Start

March 1, 2004

Study Completion

September 1, 2006

Last Updated

July 6, 2011

Record last verified: 2006-03

Locations

NO(1)