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Therapeutic Safety and Efficacy of REP 9AC (REP 2055) in HBV or HCV Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02646163
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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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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 (HBV):

  • HBsAg+ for at least 6 months prior to initiation of treatment.
  • HBeAg+
  • HBV titer > 20000 copies/ml at start of treatment
  • Treatment naïve
  • HIV / hepatitis delta / HCV negative
  • Compensated liver disease
  • Ishak score ≤ 2
  • Non cirrhotic
  • No known active cytomegalovirus infection
  • Willingness to utilize adequate contraception while being treated with REP 9AC (REP 2055) and for 6 months following the end of treatment
  • Adequate venous access allowing weekly intravenous therapies and blood tests

Inclusion Criteria (HCV):

  • HCV positive for at least 6 months prior to initiation of treatment
  • Genotype 3
  • HCV titer >3log IU/ml at start of treatment
  • Treatment naïve
  • HIV / hepatitis delta / HBV negative
  • Compensated liver disease
  • Chronic alanine aminotransferase or aspartate aminotransferase elevation for 6 months prior to treatment
  • Ishak score ≤ 2 (patients should only have mild fibrosis)
  • Non cirrhotic
  • No known active cytomegalovirus infection
  • Willingness to utilize adequate contraception while being treated with REP 9AC (REP 2055) and for 6 months following the end of treatment
  • Adequate venous access allowing weekly intravenous therapies and blood tests

Exclusion Criteria (HBV + HCV):

  • 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
  • Anti-HIV 1: 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%
  • Alfa 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
  • Platelets 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 undergo a liver biopsy.
  • Inability or unwillingness to provide weekly blood samples
  • Poor venous access making weekly 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): NCT02646163


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: NCT02646163    
Other Study ID Numbers: REP 101
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
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic