Thymosin Alpha-1 in Combination With Peg-Interferon Alfa- 2a and Ribavirin for the Therapy of Chronic Hepatitis C Nonresponsive to the Combination of IFN and Ribavirin.

What Was Tested

This registered phase 3 trial tested Thymosin Alpha-1.

It had two arms (groups): Thymosin alpha 1 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as biological and drug.

Who Took Part

The registry lists 552 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Signed written informed consent. Presence of HCV RNA measured by quantitative PCR. Wash-out period of at least 6 months from previous therapy with PEGinterferon alpha plus ribavirin.

The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: use of systemic corticosteroids within 6 months of entry; more than one previous course of therapy with peginterferon alpha plus ribavirin; any other liver disease.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Thymosin Alpha-1 group and the comparison group should start out alike.

The Thymosin Alpha-1 group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Thymosin Alpha-1, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2004-12 with completion listed for 2008-05.

It ran at 9 sites in Italy (5), France (1), Germany (1), Greece (1) and Spain (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Sustained Virological Response (SVR) (time frame: Week 72).

It also tracked 4 secondary outcomes, for example Sustained Biochemical Response (SBR), End of Treatment Biochemical Response (EBR), End of Treatment Virological Response [EVR] and Safety.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Thymosin Alpha-1 in 552 people.

With 552 participants it is a large trial for this field.

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.