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PEG-IFN alfa-2a, Tenofovir

Phase 2

Hepatitis D | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Jan 29, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

PEG-IFN alfa-2a, Tenofovir · 1 trial · 1 indication

Phase 2 1
NCT00932971HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta HepatitisHepatitis D
COMPLETED70 Analytics
PHASE2COMPLETED
HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta Hepatitis
Hepatitis DUnlock trial analytics

Study Endpoints

Primary Endpoints

Negativation of HDV-RNA at the end of therapy
week 96

Secondary Endpoints

Negativation of HDV-RNA at week 48 of treatment
week 48
Negativation of HDV-RNA 24 weeks after the end of treatment
week 120
Normalization of ALT levels at the end of treatment and at the end of follow-up
week 96 and week 356
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PEG-IFN alfa-2a plus placeboPLACEBO_COMPARATORPegylated interferon alfa-2a 180 µg once weekly (QW) subcutaneous (sc) plus placebo once daily, orally
PEG-IFN alfa-2a plus TenofovirACTIVE_COMPARATORPegylated interferon alfa-2a 180 µg once weekly (QW) subcutaneous (sc) plus Tenofovir disoproxilfumarat 245mg once daily, orally

Interventions

NameTypeDescription
PEG-IFN alfa-2a, TenofovirDRUGPegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Tenofovir disoproxilfumarat, 245mg, once daily, orally
PEG-IFN alfa-2a, placeboDRUGPegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Placebo, once daily, orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Written informed consent. * Age \> 18 years. * Positive HBsAg, for at least the prior 6 months, positive anti-HDV for at least 3 months and positive for HDV-RNA by PCR within the screening period. * Elevated serum ALT ≥ ULN but ≤ 10X ULN as determined by two abnormal values ta...

Countries:GermanyGreeceRomania
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Competitive Landscape -Hepatitis D 8 trials

Frequently asked questions about PEG-IFN alfa-2a, Tenofovir

What is PEG-IFN alfa-2a, Tenofovir used for in Hepatitis D?

PEG-IFN alfa-2a, Tenofovir is used for the treatment of Hepatitis D, a chronic viral infection of the liver. It is being studied as a combination therapy to evaluate its efficacy and safety in patients with this condition.

Who makes PEG-IFN alfa-2a, Tenofovir?

PEG-IFN alfa-2a, Tenofovir is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD.

What phase is PEG-IFN alfa-2a, Tenofovir in?

PEG-IFN alfa-2a, Tenofovir is in Phase 2 clinical development. It is an investigational combination therapy and has not been approved by regulatory authorities for the treatment of Hepatitis D.

What clinical trials is PEG-IFN alfa-2a, Tenofovir in?

PEG-IFN alfa-2a, Tenofovir has been studied in one completed Phase 2 clinical trial, identified as NCT00932971, titled 'HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta Hepatitis'. This trial enrolled 70 participants and was conducted in Germany, Greece, and Romania.

Is PEG-IFN alfa-2a, Tenofovir the same as PegIFN-alfa2a plus Tenofovir?

Yes, PEG-IFN alfa-2a, Tenofovir is the same as PegIFN-alfa2a plus Tenofovir. The combination therapy is referred to by both names, with the clinical trial NCT00932971 using the latter designation.