Therapeutic Safety and Efficacy of REP 9AC (REP 2055) in HBV or HCV Infected Patients
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|ClinicalTrials.gov Identifier: NCT02646163|
Recruitment Status : Completed
First Posted : January 5, 2016
Last Update Posted : January 5, 2016
REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry activity against hepatitis C virus and entry and post-entry antiviral activity against duck hepatitis B virus (DHBV) infection. REP 2055 has been shown to have potent prophylactic effect against HCV infection in vivo and potent therapeutic effect against established DHBV infection in vivo
The REP 101 protocol is the first-in-man proof of concept study designed to investigate the safety and antiviral activity of REP 2055 administration in human patients with chronic HBV or HCV infection.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B, Chronic||Drug: REP 2055||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapeutic Safety and Efficacy of REP 9AC (REP 2055) in HBV or HCV Infected Patients|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: REP 2055
Treatment with REP 2055
Drug: REP 2055
(First two patients) REP 2055 is administered once weekly by slow IV infusion in dose escalation from 100 to 1200mg until a grade 3 adverse event is observed not to exceed 40 weeks of dosing.
(Subsequent patients) 400mg of REP 2055 is administered by slow IV infusion. First week of infusion to include daily dosing followed by twice weekly dosing for 40 weeks.
Other Name: REP 9AC
- Safety and tolerability of REP 2055 treatment [ Time Frame: 40 weeks (treatment) ]To record side effects, symptoms and adverse effects of REP 2055 exposure including laboratory test abnormalities.
- Efficacy of REP 2055 treatment [ Time Frame: 40 weeks (treatment) + 57 weeks (follow up) ]To assess antiviral activity of REP 2055 including serum HBsAg, HBeAg, anti-HBsAg antibodies, anti-HBeAg antibodies and HBV DNA.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646163
|Farabi General Hospital|
|Dhaka, Bangladesh, 1213|
|Principal Investigator:||Mamun Al-Mahtab, MD||Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh|