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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B Virus

Intervention: pegIFN (Drug); pegIFNα-2a (Drug); PegIFN lambda (Drug); Entecavir (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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

Clinical Details

Official title: Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients With Chronic Hepatitis B Virus Infection Who Are HBeAg-positive

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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

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

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

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

Secondary outcome:

Part A: Proportion of subjects who achieve an hepatitis B virus Deoxyribonucleic acid levels (HBV DNA) < 50 IU/mL (approximately 300 copies/mL) using the Roche COBAS® TaqMan - High Pure System (HPS) assay

Part A: Mean change from baseline in log10 HBV DNA levels over time (Proportion of subjects with Alanine amino transferase (ALT) normalization (≤ 1 x upper limit of normal (ULN))

Part A: Proportion of subjects with ALT normalization (≤ 1 x ULN)

Part A: Hepatitis E antigen (HBeAg) loss

Part A: HBeAg seroconversion

Part A: Mean change from baseline in log10 quantitative HBeAg levels over time

Part A: Number and percent of subjects with adverse events (AEs) or laboratory abnormalities

Part A: Number and percent of subjects with adverse events (AEs) or laboratory abnormalities

Part A: Pharmacokinetic (PK) parameter Maximum observed concentration (Cmax) of Pegylated interferon lambda (pegIFNλ) will be derived from serum concentration versus time data

Part A: Pharmacokinetic (PK) parameter Time of maximum observed concentration (Tmax) of Pegylated interferon lambda (pegIFNλ) will be derived from serum concentration versus time data

Part A: Pharmacokinetic (PK) parameter Trough serum concentration pre-dose (C0) of Pegylated interferon lambda (pegIFNλ) will be derived from serum concentration versus time data

Part A: PK parameter serum concentration 168 hours post observed dose [Cmin] (C0 will be used as an estimate of Cmin if sample is not collected) of pegIFNλ will be derived from serum concentration versus time data

Part A: PK parameter Area under the concentration-time curve in 1 dosing interval from time 0 to 168 hours post observed dose [AUC(TAU)] of pegIFNλ will be derived from serum concentration versus time data

Part A: PK parameter Accumulation index (AI) ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (only conducted if data warrant) of pegIFNλ will be derived from serum concentration versus time data

Part B: HBeAg seroconversion rate at 24 weeks off treatment

Part B: Antiviral activity of Lambda/ETV regimen, as determined by the proportion of subjects who achieve an HBV DNA < 50 IU/mL (approximately 300 copies/mL) using the Roche COBAS® TaqMan - HPS assay

Part B: Mean change from baseline in HBV DNA over time in subjects treated with Lambda/ETV

Part B: HBeAg loss and seroconversion in subjects treated with Lambda/ETV regimen

Part B: HBeAg levels over time in subjects treated with Lambda/ETV regimen

Part B: biochemical response rates in subjects treated with Lambda/ETV regimen

Part B: Pharmacokinetic (PK) parameter Maximum observed concentration (Cmax) of Lambda/ETV regimen will be derived from serum concentration versus time data

Part B: Pharmacokinetic (PK) parameter Time of maximum observed concentration (Tmax) of Lambda/ETV regimen will be derived from serum concentration versus time data

Part B: Pharmacokinetic (PK) parameter Trough serum concentration pre-dose (C0) of Lambda/ETV regimen will be derived from serum concentration versus time data

Part B: PK parameter Area under the concentration-time curve in 1 dosing interval from time 0 to 168 hours post observed dose [AUC(TAU)] of Lambda/ETV regimen will be derived from serum concentration versus time data

Part B: PK parameter serum concentration 168 hours post observed dose [Cmin] (C0 will be used as an estimate of Cmin if sample is not collected) of Lambda/ETV regimen will be derived from serum concentration versus time data

Part B: PK parameter Accumulation index (AI) ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (only conducted if data warrant) of Lambda/ETV regimen will be derived from serum concentration versus time data

Part B: Rate of resistance to ETV during treatment with the Lambda/ETV regimen

Detailed description: Part B sub study is Open Label

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Local Institution, Clichy Cedex 92118, France

Local Institution, Nice Cedex 03 06202, France

Local Institution, Paris Cedex 12 75571, France

Local Institution, Rennes Cedex 9 35033, France

Local Institution, Frankfurt 60590, Germany

Local Institution, Freiburg 79106, Germany

Local Institution, Hamburg 20246, Germany

Local Institution, Hannover 30625, Germany

Local Institution, Tuebingen 72076, Germany

Local Institution, Hong Kong 852, Hong Kong

Local Institution, Shatin 30-32, Hong Kong

Local Institution, Tai Po 852, Hong Kong

Local Institution, Firenze 50012, Italy

Local Institution, Roma 00161, Italy

Local Institution, Chuncheon 200-704, Korea, Republic of

Local Institution, Gyeonggi-Do 480-717, Korea, Republic of

Local Institution, Seoul 120-752, Korea, Republic of

Local Institution, Seoul 135-710, Korea, Republic of

Local Institution, Seoul 135-720, Korea, Republic of

Local Institution, Seoul 138-736, Korea, Republic of

Local Institution, Rotterdam 3015 CE, Netherlands

Local Institution, Singapore 169608, Singapore

Local Institution, Singapore 119228, Singapore

Local Institution, Kaohsiung 807, Taiwan

Local Institution, Taichung 404, Taiwan

Local Institution, Tainan 704, Taiwan

Local Institution, Taipei 100, Taiwan

Local Institution, Taipei 114, Taiwan

Local Institution, Taoyuan 333, Taiwan

Heritage Medical Research Clinic, University Of Calgary, Calgary, Alberta T2N 4Z6, Canada

Advanced Clinical Research Institute, Anaheim, California 92801, United States

Sc Clinical Research, Inc., Garden Grove, California 92844, United States

University Of California, Davis Medical Center, Sacramento, California 95817, United States

Research And Education, Inc., San Diego, California 92105, United States

Yale New Haven Hospital, New Haven, Connecticut 06520, United States

Atlanta Gastroenterology Associates, Llc, Atlanta, Georgia 30308, United States

Local Institution, Winnipeg, Manitoba R3E 3P4, Canada

Mercy Medical Center, Baltimore, Maryland 21202, United States

Gastro Center Of Maryland, Colombia, Maryland 21045, United States

Local Institution, Camperdown, New South Wales 2050, Australia

Local Institution, Liverpool, New South Wales 2170, Australia

Local Institution, Westmead Nsw, New South Wales 2145, Australia

Medical Procare, Pllc, Flushing, New York 11355, United States

Office Of Sing Chan Md, Flushing, New York 11355, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada

Toronto Western Hospital University Health Network, Toronto, Ontario M5T 2S8, Canada

Oregon Health & Science University, Portland, Oregon 97239, United States

University Of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States

Local Institution, Clayton Vic, Victoria 3168, Australia

Local Institution, Heidelberg Vic, Victoria 3084, Australia

Local Institution, Melbourne, Victoria 3004, Australia

Local Institution, Fremantle, Western Australia 6160, Australia

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: November 2010
Last updated: July 23, 2014

Page last updated: August 23, 2015

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