Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients
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| ClinicalTrials.gov Identifier: NCT02646189 |
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Recruitment Status :
Completed
First Posted : January 5, 2016
Last Update Posted : January 5, 2016
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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 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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. Drug: Zadaxin Zadaxin is administered twice weekly (1.6mg) by subcutaneous injection
Other Name: thymosin alpha 1 Drug: Pegasys 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.
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HBsAg+
- Anti-HBs negative
- HBV titer > 1x10^7 copies / ml
- Treatment naïve
- HIV / HCV / hepatitis delta virus negative
- Fibrosis with compensation (as determined by Fibroscan and liver enzymes)
- Non cirrhotic
- No known active cytomegalovirus infection
- Willingness to utilize adequate contraception while being treated with REP 9AC' and for 6 months following the end of treatment
- Adequate venous access allowing weekly intravenous therapies and blood tests
Exclusion Criteria:
- Evidence of cardiovascular disease
- Autoimmune hepatitis
- Presence of Wilson's disease
- Presence of severe NAFLD
- Evidence of any other co-existent liver disease
- Anti-nuclear antibody positive
- Evidence of liver cirrhosis
- A history of ascites, hepatic encephalopathy or variceal hemorrhage
- Body weight > 100 kg
- Platelet count < 75,000, polymorphonuclear cell count < 1,500 or hematocrit < 33%
- Alpha feto protein > 100 ng/ml or the presence of a hepatic mass suggestive of hepatocellular carcinoma .
- Bilirubin > 2.5 mg/dl
- Creatinine > 1.5 mg/dl
- Platelet count < 75,000 / cmm
- Serum albumin < 35 mg/ml
- Poorly controlled diabetes mellitus
- Another serious medical disorder
- A serious psychiatric disorder
- Uncontrolled hypertension
- A history of alcohol abuse within the last year
- The use of illicit drugs within the past two years
- Inability to provide informed consent
- Positive pregnancy test
- Breastfeeding
- Inability or unwillingness to provide weekly blood samples
- Poor venous access making IV infusion too difficult
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
| Bangladesh | |
| Farabi General Hospital | |
| Dhaka, Bangladesh, 1213 | |
| Principal Investigator: | Mamun Al-Mahtab, MD | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Replicor Inc. |
| ClinicalTrials.gov Identifier: | NCT02646189 History of Changes |
| Other Study ID Numbers: |
REP 102 |
| First Posted: | January 5, 2016 Key Record Dates |
| Last Update Posted: | January 5, 2016 |
| Last Verified: | January 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
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Hepatitis B Hepatitis B, Chronic Hepadnaviridae Infections DNA Virus Infections Virus Diseases Hepatitis, Viral, Human Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic Interferons |
Interferon alpha-2 Interferon-alpha Peginterferon alfa-2a Thymalfasin Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |