Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B

NCT02726789 | Completed Phase 2 Results

• 1 other identifier: REP 201
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

The REP 201 protocol is a small exploratory study assessing the antiviral effects and tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks) in treatment naive patients or in patients already receiving entecavir and continuing entecavir with treatment.

Conditions

Hepatitis B, Chronic

Keywords

nucleic acid polymer REP 2139 HBsAg hepatitis B

Outcome Measures

Primary Outcomes (1)

• Number of Patients Experiencing Treatment Emergent Laboratory Test Abnormalities or Adverse Events.

  To record side effects, symptoms and adverse effects of exposure to REP 2139-Ca when combined pegylated interferon.

  48 weeks (treatment)

Secondary Outcomes (3)

• Number of Patients Experiencing Reductions in Serum HBsAg

  48 weeks (treatment)

• Number of Patients Experiencing Reductions in Serum HBV DNA

  48 weeks (treatment)

• Number of Patients Experiencing Serum Anti-HBs > 10 mIU / ml

  48 weeks (treatment)

Study Arms (1)

Experimental

EXPERIMENTAL

Patients either treatment naive or with HBV DNA controlled with entecavir receive REP 2139-Ca in combination with pegylated interferon. Only patients receiving entecavir at enrollment continue to receive entecavir during treatment in the study.

Drug: REP 2139-Ca; Drug: pegylated interferon; Drug: entecavir

Interventions

REP 2139-Ca DRUG

the nucleic acid polymer REP 2139 formulated as a calcium chelate complex

Experimental

pegylated interferon DRUG

immunotherapy

Also known as: pegylated interferon alpha 2a, Pegasys(R)

Experimental

entecavir DRUG

local generic entecavir

Also known as: local generic entecavir

Experimental

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 55
• HBsAg+
• Anti-HBs negative
• Patients currently receiving nucleoside based HBV polymerase inhibitors may be included in the study at the discretion of the Principle Investigator.
• HIV / hepatitis C / 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

You may not qualify if:

• 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
• Ultrasonograph of hepato-biliary system: positive for cirrhosis of liver
• 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

Sponsors & Collaborators

• Replicor Inc.: lead

Related Publications (3)

• Noordeen F, Vaillant A, Jilbert AR. Nucleic acid polymers inhibit duck hepatitis B virus infection in vitro. Antimicrob Agents Chemother. 2013 Nov;57(11):5291-8. doi: 10.1128/AAC.01003-13. Epub 2013 Aug 12.

  PMID: 23939902 BACKGROUND

• Noordeen F, Vaillant A, Jilbert AR. Nucleic acid polymers prevent the establishment of duck hepatitis B virus infection in vivo. Antimicrob Agents Chemother. 2013 Nov;57(11):5299-306. doi: 10.1128/AAC.01005-13. Epub 2013 Aug 12.

  PMID: 23939904 BACKGROUND

• Noordeen F, Scougall CA, Grosse A, Qiao Q, Ajilian BB, Reaiche-Miller G, Finnie J, Werner M, Broering R, Schlaak JF, Vaillant A, Jilbert AR. Therapeutic Antiviral Effect of the Nucleic Acid Polymer REP 2055 against Persistent Duck Hepatitis B Virus Infection. PLoS One. 2015 Nov 11;10(11):e0140909. doi: 10.1371/journal.pone.0140909. eCollection 2015.

  PMID: 26560490 BACKGROUND

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Replicor Inc.

availlant@replicor.com

514 733 1998

Study Officials

• Mamun Al-Mahtab, MD

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 4, 2016
• Study Start: October 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 8, 2019
• Results First Posted: May 8, 2019

Record last verified: 2017-02