Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients

What Was Tested

This registered phase 1, phase 2 trial tested Thymosin Alpha-1.

REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry and post-entry antiviral activity against duck hepatitis B virus (DHBV) infection.

It had 1 arm (groups): REP 2139-Ca + immunotherapy (experimental).

The registry classes the interventions as drug.

More on the Plan

Chronic hepatitis B is a long term condition caused by infection of the body with the hepatitis B virus (HBV).

This infection often results in inflammation or scarring of the liver and can eventually lead to liver cirrhosis and liver failure.

These infections are also one of the major causes of the development of hepatocellular carcinoma (liver cancer).

Nucleic acid-based polymers (NAPs) are a new class of broad-spectrum antiviral compounds which act against HBV infection by blocking the release of the surface antigen protein (HBsAg) from infected hepatocytes.

Who Took Part

12 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: HBV titer \> 1x10\^7 copies / ml. HIV / HCV / hepatitis delta virus negative. Fibrosis with compensation (as determined by Fibroscan and liver enzymes). 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.

The full record lists 10 inclusion and 26 exclusion criteria; among the exclusions: evidence of cardiovascular disease; autoimmune hepatitis; presence of wilson's disease.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Thymosin Alpha-1 study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-08 with completion listed for 2013-08.

It ran at 1 site in Bangladesh.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Safety and tolerability of REP 2139-Ca + immunotherapy (time frame: 40 weeks (treatment)).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Thymosin Alpha-1 in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Thymosin Alpha-1 compound page, all human trials.