Recent Updates
Recently added Catalysts

Peginterferon Alfa-2a and Ribavirin

Phase 2

Hepatitis C | Small molecule | Hematology |Elevance Health, Inc.|Last Updated: Mar 4, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

Peginterferon Alfa-2a and Ribavirin · 1 trial · 2 indications

Phase 2 1
NCT00502788Evaluating the Safety of Two Medications to Treat Hepatitis C in People With Thalassemia (The HepC Study)Hepatitis C
COMPLETED21 Analytics
PHASE2COMPLETED
Evaluating the Safety of Two Medications to Treat Hepatitis C in People With Thalassemia (The HepC Study)
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of peginterferon alfa-2a and ribavirin in individuals with thalassemia (measured by changes in liver iron stores and development of iron overload-related complications)
Measured at Week 72

Secondary Endpoints

Mean change in hepatic iron concentration from baseline biopsy to follow-up biopsy; relationship of change to baseline level
Measured at Week 48
Transfusion frequency and volume required to maintain trough Hb 9.0-10.5 g/dL during treatment, as compared to that required in the 6 months prior to hepatitis C treatment
Measured at Week 72
Cumulate change in deferoxamine dose; evidence for deferoxamine toxicity during hepatitis C treatment
Measured at Week 72
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Peginterferon Alfa-2a and RibavirinDRUGPatients will be treated with alfa-2a and ribavirin as follows: Peginterferon alfa-2a will be started as a dose of 180 ug subcutaneously once weekly.
RibavirinDRUGRibavirin will be started at a dose of 800mg daily for those weighing less than or equal to 50 kg, 1000 mg daily for those with body weight 51 to 75 kg and 1200 mg daily for those with body weight \> 75 kg. Ribavirin will be given orally in two divided doses. The lower dose has been included because potentially-eligible patients in the TCRN registry have a mean weight of 57 kg.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 44 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Diagnosis of thalassemia * Serum positive for hepatitis C virus RNA by polymerase chain reaction (PCR) test (using the Roche COBAS Amplicor hepatitis C virus test) * Hepatitis B surface antigen (HBsAg) negative and HIV negative within the 12 months prior to study entry * Liver...

Countries:United StatesCanadaUnited Kingdom
Unlock Eligibility Criteria

Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about Peginterferon Alfa-2a and Ribavirin

What is Peginterferon Alfa-2a and Ribavirin used for?

Peginterferon Alfa-2a and Ribavirin is a combination therapy used for the treatment of Hepatitis C. It is being studied in patients who also have thalassemia, a blood disorder. The drug is currently in Phase 2 clinical development and is considered investigational.

Who makes Peginterferon Alfa-2a and Ribavirin?

Peginterferon Alfa-2a and Ribavirin is being developed by Elevance Health, Inc., a company traded on the stock exchange under the ticker symbol ELV. The company is conducting clinical research to evaluate the safety and efficacy of this combination therapy for Hepatitis C.

What phase is Peginterferon Alfa-2a and Ribavirin in?

Peginterferon Alfa-2a and Ribavirin is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed to assess its safety in patients with Hepatitis C and thalassemia.

What clinical trials is Peginterferon Alfa-2a and Ribavirin in?

Peginterferon Alfa-2a and Ribavirin has been studied in one completed clinical trial, identified as NCT00502788. This Phase 2 study, titled 'Evaluating the Safety of Two Medications to Treat Hepatitis C in People With Thalassemia (The HepC Study)', enrolled 21 participants across the United States, Canada, and the United Kingdom.

Is Peginterferon Alfa-2a and Ribavirin FDA approved?

Peginterferon Alfa-2a and Ribavirin is not FDA approved. It is an investigational combination therapy currently in Phase 2 clinical development for Hepatitis C. The drug has not completed the clinical trial process required for regulatory approval and remains under investigation.