Clinical trial NCT01833845
Conditions: Hepatitis C
Keywords: HCV Hepatitis C Hep-C
Sponsor: BioLineRx, Ltd.
Start date: 2013-04-01; Completion date: 2014-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Detailed description:
Patients who provide their informed consent and conform to all the inclusion and none of the exclusion criteria will be enrolled into the study and will receive RBV monotherapy for 8 weeks. Subjects will receive 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.

During Treatment Period 2, subjects will receive HCQ 575 mg administered as a single tablet once daily (QD), in addition to continuing the same dose of RBV that was administered during Treatment Period 1, as combination therapy for up to 16 weeks.

Subjects will undergo regular blood sampling throughout Treatment Periods 1 and 2 to measure viral response (HCV RNA). Safety will be assessed throughout the study by collection of adverse event (AE) and concomitant medication data, and routine monitoring of laboratory safety tests, vital signs and 12-lead electrocardiograms (ECG).

Subjects will have their viral response tested following 12 weeks of combination therapy; those who show \< 1 log decline in viral load during the combination therapy will have the opportunity to withdraw and transfer to standard of care (SoC) treatment following performance of the "End of Study Treatment" visit.

On completion of study treatment, subjects will be allowed to transfer immediately to SoC treatment in order to maximize the benefit of any reduced viral load resulting from combination therapy with RBV plus HCQ. Subjects will attend the clinical site for an "End of Study Treatment" visit within 2 weeks of the final dose of combination treatment with RBV plus HCQ during which they will undergo a final measurement of HCV RNA, safety assessments as described above and a full physical and ophthalmic examination. The "End of Study Treatment" visit may take place on the same day as the final study visit at week 24.

In the event of subjects achieving viral undetectability during combination therapy, the relevant subjects may be administered additional combination therapy to achieve a total of 24 weeks of viral undetectability. If combination dosing with RBV plus HCQ continues for more than 16 weeks, subjects will continue to attend the clinical site and undergo assessment of safety and viral load at the discretion of the Investigator. However, treatment beyond 16 weeks of combination therapy will be considered compassionate use and will not be considered part of the study. In these subjects, the "End of Study Treatment" visit will take place no more than 2 weeks after the Week 24 visit.

Arms: arm 1: Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).
Interventions: intervention 1: Ribavirin intervention 2: Hydroxychloroquine
Intervention descriptions: intervention 1: 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. intervention 2: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)

Protocol documents: