NCT00484328

Brief Summary

The purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2007

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2007

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 9, 2018

Status Verified

July 1, 2011

Enrollment Period

5.4 years

First QC Date

June 7, 2007

Last Update Submit

January 5, 2018

Conditions

Hepatitis C

Keywords

hepatitis CRibavirinDosagePharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph

    within 24 weeks after enrollment

Secondary Outcomes (4)

  • The tolerability of the treatment at different dosage regimes of ribavirin

    24 weeks of treatment

  • The antioxidant capacity in plasma and erythrocytes at different dosing regimes

    24 weeks of treatment

  • The effect of ribavirin on the hemolysis

    24 weeks of treatment

  • The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes

    24 weeks of treatment

Study Arms (2)

1

EXPERIMENTAL
Drug: Ribavirin

2

EXPERIMENTAL
Drug: Ribavirin

Interventions

RibavirinDRUG

different dosing regimes of Ribavirin

12

Eligibility Criteria

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

You may qualify if:

  • anti-HCV positivity \> 6 months
  • Positive HCV-RNA genotype 1 or 4
  • Liver biopsy within one year before the start of therapy
  • Intention to be treated and participate treatment
  • body weight at or above 75 kg

You may not qualify if:

  • HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maastricht

Maastricht, 6229 ER, Netherlands

Location

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

  • Aalt Bast, Prof.Dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2007

First Posted

June 8, 2007

Study Start

July 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 9, 2018

Record last verified: 2011-07

Locations

NL(1)