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Pegylated Interferon

Phase 2

Chronic Hepatitis B | Small molecule | Infectious Disease |GSK plc|Last Updated: Oct 24, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Pegylated Interferon · 1 trial · 1 indication

Phase 2 1
NCT00226447Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in Chronic Hepatitis B PatientsChronic Hepatitis B
COMPLETED30 Analytics
PHASE2COMPLETED
Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in Chronic Hepatitis B Patients
Chronic Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

HBV DNA reduction at week 52

Secondary Endpoints

Normalization of ALT & negative HBV DNA at EOT, negative HBV DNA at EOT & 24 weeks after cessation of treatment, normalization of ALT at the end of treatment and 24 weeks after the cessation of treatment, Safety of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Pegylated InterferonDRUG -
LamivudineDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * HBsAg positive for at least 6 months prior to screening * Serum HBV-DNA \> 10\^6 copies per ml at screening * Serum HBeAg positive at screening * Abnormal ALT (1.3-10x upper limit normal) within one month prior to entry * Compensated liver disease with the following minimum cr...

Countries:China
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Frequently asked questions about Pegylated Interferon

What is Pegylated Interferon used for in Chronic Hepatitis B?

Pegylated Interferon is used for the treatment of Chronic Hepatitis B, a viral infection that affects the liver. It is being investigated as a therapy to manage this condition, with clinical trials evaluating its effectiveness in patients with the disease.

Who makes Pegylated Interferon?

Pegylated Interferon is being developed by GSK plc, a global biopharmaceutical company. GSK is conducting clinical research to evaluate the drug's potential in treating Chronic Hepatitis B, with the company's stock traded under the ticker symbol GSK.

What phase is Pegylated Interferon in?

Pegylated Interferon is currently in Phase 2 clinical development for Chronic Hepatitis B. This means it is in the second stage of human testing, where researchers are evaluating its efficacy and safety in a larger group of patients. It is still investigational and not yet approved for commercial use.

What clinical trials is Pegylated Interferon in?

Pegylated Interferon has been studied in a completed Phase 2 clinical trial with the identifier NCT00226447. This trial, titled "Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in Chronic Hepatitis B Patients," enrolled 30 participants in China and evaluated the drug's effects in adults aged 18 years and older.

Is Pegylated Interferon the same as other interferon drugs?

Pegylated Interferon is a specific form of interferon that has been modified with polyethylene glycol to extend its activity in the body. While it belongs to the broader class of interferon therapies, it is distinct in its formulation and is being studied specifically for Chronic Hepatitis B.