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CPG10101

Phase 2

Hepatitis, Chronic Active | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Mar 8, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment204

FDA Designations

No designations recorded

Clinical trial landscape

CPG10101 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT00277238CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected SubjectsHepatitis, Chronic Active
COMPLETED113 Analytics
PHASE2COMPLETED
CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Hepatitis, Chronic ActiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Serum HCV RNA concentrations, over 12wks, relative to baseline, early virologic response (EVR)
12wks
Serum HCV RNA concentrations, 6months after treatment completed, relative to baseline, sustained virologic response (SVR)
72wks
Adverse events, vital signs, clinical and laboratory parameters, physical exam, ECG
16wks

Secondary Endpoints

Safety and Tolerability: adverse events, vital signs, clinical and laboratory parameters, depression score, physical exam, electrocardiogram (ECG), ophthalmologic exam (if required)
28wks
Dose exposure
24wks
Child-Pugh score
24wks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CPG10101 (0.2) + pegylated inteferon + ribavirinEXPERIMENTAL -
CPG10101 (0.5) + pegylated inteferon + ribavirinEXPERIMENTAL -
Pegylated interferon + ribavirinACTIVE_COMPARATOR -
CPG10101 + pegylated interferon + ribavirin (rollover)EXPERIMENTAL -
CPG10101EXPERIMENTAL -
CPG10101 + pegylated interferonEXPERIMENTAL -
CPG10101 + ribavirinEXPERIMENTAL -
CPG10101 + pegylated interferon + ribavirinEXPERIMENTAL -
Pegylated inteferon + ribavirinACTIVE_COMPARATOR -

Interventions

NameTypeDescription
CPG10101DRUGCPG10101, subcutaneous, 0.2mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
ControlDRUGPegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 12wks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: HCV positive subjects documented by serum HCV RNA concentration \> 100,000 IU/mL within 21 days of first study treatment Receipt of adequate previous PEG-IFN and RBV therapy for a minimum of 12 weeks (PEG-IFN alpha-2a doses of \> 180 μg/wk or PEG-IFN alpha-2b 1.5 µg/kg/wk and at...

Countries:United States
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Frequently asked questions about CPG10101

What is CPG10101 used for?

CPG10101 is an investigational small molecule being studied for the treatment of chronic active hepatitis, specifically in patients with hepatitis C virus (HCV) infection. It has been evaluated in clinical trials as a combination therapy for relapsed HCV subjects and for non-responder HCV genotype 1 infected subjects.

Who makes CPG10101?

CPG10101 is being developed by Pfizer, Inc., a biopharmaceutical company publicly traded under the ticker symbol PFE on the New York Stock Exchange.

What phase is CPG10101 in?

CPG10101 is in Phase 2 clinical development. It has completed two clinical trials, including one Phase 1 study and one Phase 2 study. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is CPG10101 in?

CPG10101 has been studied in two completed clinical trials. NCT00142103 was a Phase 1 study of CPG10101 combination therapy for relapsed hepatitis C virus subjects with 91 participants. NCT00277238 was a Phase 2 study in non-responder HCV genotype 1 infected subjects with 113 participants.

How does CPG10101 work?

CPG10101 is a small molecule therapeutic. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated as a combination therapy for chronic active hepatitis C virus infection.