Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and Hydroxychloroquine in Patients Infected With Hepatitis C (NCT NCT01833845)

Last Updated: 2014-08-28

Results Overview

To evaluate the effect of 16-week combination therapy with RBV plus HCQ following 8 weeks of monotherapy with RBV in HCV-infected patients.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

24 weeks

Results posted on

2014-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Ribavirin+HCQ 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). 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. Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ribavirin+HCQ n=4 Participants 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). 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. Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)
Age, Continuous	57.8 years STANDARD_DEVIATION 6.0 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment France	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

To evaluate the effect of 16-week combination therapy with RBV plus HCQ following 8 weeks of monotherapy with RBV in HCV-infected patients.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: all 24 weeks

Safety was assessed throughout study by collection of adverse event and concomitant medication data, and routine monitoring of lab safety tests, physical exams, ophthalmic examination, vital signs and 12 lead electrocardiograms.

Outcome measures

Outcome measures
Measure	Ribavirin+HCQ n=4 Participants 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). 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. Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)
Safety: Number of Participants With Adverse Events	4 participants

SECONDARY outcome

Timeframe: 8 weeks

To evaluate the efficacy of 8 weeks monotherapy with RBV in HCV-infected patients.

Outcome measures

Outcome data not reported

Adverse Events

Ribavirin+HCQ

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ribavirin+HCQ n=4 participants at risk 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). 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. Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)
Gastrointestinal disorders Upper abdominal pain	25.0% 1/4 • Number of events 1
Gastrointestinal disorders Gastroesophageal reflux disease	25.0% 1/4 • Number of events 1
Nervous system disorders Headache	25.0% 1/4 • Number of events 1
Nervous system disorders Dysgeusia	25.0% 1/4 • Number of events 1
Gastrointestinal disorders Asthenia	50.0% 2/4 • Number of events 2
Psychiatric disorders insomnia	50.0% 2/4 • Number of events 2
Eye disorders dry eye	25.0% 1/4 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 1/4 • Number of events 1
Respiratory, thoracic and mediastinal disorders cough	25.0% 1/4 • Number of events 1
Vascular disorders Hypertension	25.0% 1/4 • Number of events 1

Additional Information

Dr. Arnon Aharon

BioLineRx LTD

Phone: 972-2-548-9100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The publication of the results of the Research in their entirety or in part, will be at the sole initiative of BIOLINERX Ltd. Reference to the results of the search cannot be made without the prior written agreement of BioLineRx Ltd..
Publication restrictions are in place

Restriction type: OTHER