Combination therapy with thymosin alpha1 and interferon for the treatment of chronic hepatitis C infection: a randomized, placebo-controlled double-blind trial

What Was Tested

The paper reports a study of Thymosin Alpha-1, published as a randomized controlled trial.

The researchers evaluated the addition of thymosin alpha1 (TA1), an immunomodulatory peptide, to the standard treatment regimen for hepatitis C to determine if combination therapy shows biological activity using outcome measures including normalization of alanine aminotransferase levels, histological activity, and viral load during treatment.

The researchers performed a randomized, double-blind, placebo-controlled trial to compare the biological activity of a combination TA1 and IFN with that seen for IFN alone in patients with chronic hepatitis C infection.

Why It Was Studied

Hepatitis C is a major cause of liver disease leading to cirrhosis.

All patients had chronic HCV infection with confirmation of chronic hepatitis on liver biopsy.

Who Took Part

The age groups tagged for this paper are adults and middle-aged adults, both men and women.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Random assignment meant chance, not the researchers, decided who got Thymosin Alpha-1 and who got the comparison, which limits bias.

Blinding on both sides kept the participants and researchers unaware of who received Thymosin Alpha-1.

The comparison arm used a placebo, so changes seen with Thymosin Alpha-1 could be set against what happens without it.

What Was Measured

The groups were similar with regard to sex, gender distribution, baseline histological activity index (HAI) score, risk factors, and viral titers.

PubMed files the paper under topics including Antiviral Agents, Hepatitis C, Chronic, Interferon alpha-2, Interferon-alpha, RNA, Viral, Recombinant Proteins and Thymalfasin.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Thymosin Alpha-1.

The publication is from 1998 (Hepatology (Baltimore, Md.)), a journal based in United States.

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