CompletedPhase 2

Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen

United States197 participantsStarted 2010-11

Plain-language summary

At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious for the treatment of chronic hepatitis B virus infection (CHB) Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain preliminary data on the safety of pegylated interferon Lambda (Lambda) when administered in combination with Entecavir(ETV) to patients with hepatitis E antigen-positive (HBeAg-positive) chronic hepatitis B(CHB) infection employing a sequential therapy approach

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infection with the hepatitis B virus (HBV) and positive for the hepatitis B e antigen * Between the ages of 18 and 70 * Have not been previously treated with an interferon * HBV nucleos(t)ide-naive Exclusion Criteria: * Not infected with the hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV) * Do not have a serious liver, psychiatric, blood, thyroid, lung, heart or eye disease * Able to tolerate oral medication

What they're measuring

Part A: Proportion of subjects who achieve Hepatitis B e antigen (HBeAg) seroconversion

Timeframe: 24 weeks post-dosing (Week 72)

Part A: Number and percent of subjects with serious adverse events (SAEs) and discontinuations due to adverse events

Timeframe: Week 24

Part A: Number and percent of subjects with serious adverse events (SAEs) and discontinuations due to adverse events

Timeframe: 24 weeks post-dosing (Week 72)

Part B: Safety and tolerability of Lambda/ETV regimen as measured by the frequency of SAEs and discontinuations due to AEs

Timeframe: Up to 84 Weeks

Trial details

NCT IDNCT01204762

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Hepatitis B Virus trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part A: Proportion of subjects who achieve Hepatitis B e antigen (HBeAg) seroconversion

Timeframe: 24 weeks post-dosing (Week 72)

Part A: Number and percent of subjects with serious adverse events (SAEs) and discontinuations due to adverse events

Timeframe: Week 24

Part A: Number and percent of subjects with serious adverse events (SAEs) and discontinuations due to adverse events

Timeframe: 24 weeks post-dosing (Week 72)

Part B: Safety and tolerability of Lambda/ETV regimen as measured by the frequency of SAEs and discontinuations due to AEs

Timeframe: Up to 84 Weeks