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pegIFN

Phase 2

Hepatitis B Virus | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Oct 9, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment197

FDA Designations

No designations recorded

Clinical trial landscape

pegIFN · 1 trial · 1 indication

Phase 2 1
NCT01204762Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e AntigenHepatitis B Virus
COMPLETED197 Analytics
PHASE2COMPLETED
Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen
Hepatitis B Virus
NCT01204762197
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Study Endpoints

Primary Endpoints

Part A: Proportion of subjects who achieve Hepatitis B e antigen (HBeAg) seroconversion
24 weeks post-dosing (Week 72)
Part A: Number and percent of subjects with serious adverse events (SAEs) and discontinuations due to adverse events
Week 24
Part B: Safety and tolerability of Lambda/ETV regimen as measured by the frequency of SAEs and discontinuations due to AEs
Up to 84 Weeks

Secondary Endpoints

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
Weeks 24, 48, 72, 96, 120, 144, 168 and 192
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))
Baseline (Day 1), Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Part A: Proportion of subjects with ALT normalization (≤ 1 x ULN)
Weeks 24, 48, 72, 96, 120, 144, 168 and 192
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A Arm 1: pegIFN (180 μg)EXPERIMENTAL -
Part A Arm 2: pegIFNα-2aACTIVE_COMPARATOR -
Part B: pegIFN lambda + EntecavirEXPERIMENTAL -

Interventions

NameTypeDescription
pegIFNDRUGSyringe, Subcutaneous, 180 μg, Once Weekly, 48 weeks
pegIFNα-2aDRUGSyringe, Subcutaneous 180 μg, Once Weekly, 48 Weeks
PegIFN lambdaDRUGSyringe, Subcutaneous, 180 µg, Once weekly, 48 weeks
EntecavirDRUGTablet, Oral, 0.5 mg, Once daily, 12 weeks initial monotherapy followed by 48 weeks of combination therapy with PegIFN lambda
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites53

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), hepatiti...

Countries:United StatesAustraliaCanadaFranceGermanyHong KongItalyNetherlandsSingaporeSouth KoreaTaiwan
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Frequently asked questions about pegIFN

What is pegIFN used for in Hepatitis B Virus?

pegIFN is an investigational small molecule being studied for the treatment of Hepatitis B Virus. It is currently in Phase 2 clinical development, meaning it has not yet been approved and is still being evaluated for safety and efficacy in patients.

What does pegIFN target?

pegIFN is a pegylated interferon, which works by modulating the immune system to fight the Hepatitis B Virus. It is being studied for its ability to treat patients with Hepatitis B who are positive for the Hepatitis B e antigen.

Who makes pegIFN?

pegIFN is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the stock exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in treating Hepatitis B Virus.

What phase is pegIFN in?

pegIFN is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to determine its safety and efficacy for treating Hepatitis B Virus.

What clinical trials is pegIFN in?

pegIFN has been studied in a completed Phase 2 clinical trial with the identifier NCT01204762. This was a dose-ranging study in patients with Hepatitis B who were positive for the Hepatitis B e antigen. The trial enrolled 197 participants across multiple countries, including the United States, Australia, Canada, and several European and Asian countries.

Is pegIFN the same as pegylated interferon lambda?

pegIFN is a pegylated interferon, and the clinical trial NCT01204762 studied pegylated interferon lambda in patients with Hepatitis B. The drug is being developed by Bristol-Myers Squibb and is currently in Phase 2 development for the treatment of Hepatitis B Virus.