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Efficacy, Safety and Tolerability of Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and Hydroxychloroquine in Patients Infected With Hepatitis C

NCT01833845 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2014-08-28

Study results available
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Summary

Proof-of Concept, Open-Label, Two-Stage Study without Direct Individual Benefit The proposed study design consists of two treatment periods and one treatment arm. Treatment Period 1 involves the administration of RBV monotherapy for a period of 8 weeks and Treatment Period 2 involves administration of up to 16 weeks combination therapy with RBV plus HCQ.

Conditions

  • Hepatitis C

Interventions

DRUG

Ribavirin

weight-based doses (1000 mg/day administered BID \[twice daily\] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects \> 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.

DRUG

Hydroxychloroquine

subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)

Sponsors & Collaborators

  • BioLineRx, Ltd.

    lead INDUSTRY

Principal Investigators

  • Stanislas Pol, MD · Cochin Hospital

  • Marc Bourliere, MD · S.Joseph Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01833845 on ClinicalTrials.gov