Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients
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|ClinicalTrials.gov Identifier: NCT02646189|
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 and post-entry antiviral activity against duck hepatitis B virus (DHBV) infection. REP 2055 has been shown to have potent therapeutic effect against established DHBV infection in vivo
REP 2055 was additionally shown to have significant antiviral effects in patients with chronic HBV infection in the previous REP 101 study. REP 2139 is a version of REP 2055 designed for improved administration tolerability and stability.
The safety and antiviral activity REP 2139, first in monotherapy and then in combination with immunotherapy in patients with chronic HBV infection will be assessed in the REP 102 protocol.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B, Chronic||Drug: REP 2139-Ca Drug: Zadaxin Drug: Pegasys||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Experimental: REP 2139-Ca + immunotherapy
REP 2139-Ca is the calcium chelate complex formulation of REP 2139.
Zadaxin is thymosin alpha 1
Pegasys is pegylated interferon alpha 2a
Patients initially receiving REP 2139-Ca with no Grade 3 adverse events at week 20 are eligible to transition to combination therapy with Zadaxin if serum HBV DNA is > 2000 copies / ml.
After 10 weeks of REP 2139-Ca / Zadaxin combination therapy, patients not experiencing a measurable improvement in serum antiviral response can further transition to combination therapy with REP 2139-Ca and Pegasys.
Drug: REP 2139-Ca
REP 2139-Ca is administered weekly at 250 or 500mg doses by slow IV infusion.
Zadaxin is administered twice weekly (1.6mg) by subcutaneous injection
Other Name: thymosin alpha 1
Pegasys in administered once weekly by subcutaneous injection with dose escalation to 180ug / week.
Other Name: pegylated interferon alpha-2a
- Safety and tolerability of REP 2139-Ca + immunotherapy [ Time Frame: 40 weeks (treatment) ]To record side effects, symptoms and adverse effects of exposure to REP 2139-Ca in monotherapy and when combined with Zadaxin and / or Pegasys.
- Efficacy of REP 2139-Ca + immunotherapy [ Time Frame: 40 weeks (treatment) + 52 weeks (follow up) ]To assess antiviral activity of REP 2139-Ca in monotherapy and when combined with Zadaxin and / or Pegasus 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): NCT02646189
|Farabi General Hospital|
|Dhaka, Bangladesh, 1213|
|Principal Investigator:||Mamun Al-Mahtab, MD||Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh|