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Trial record 34 of 1135 for:    IFNA2 AND Antiviral Agents

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
Sponsor:
Information provided by (Responsible Party):
Replicor Inc.

Brief Summary:

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis B

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
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Bangladesh
Farabi General Hospital
Dhaka, Bangladesh, 1213
Sponsors and Collaborators
Replicor Inc.
Investigators
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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):
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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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Interferon-alpha
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Physiological Effects of Drugs
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic
Interferons
Peginterferon alfa-2a
Thymalfasin
Immunologic Factors
Adjuvants, Immunologic