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New Treatment Response in People With and Without Cirrhosis From Chronic Hepatitis C

NCT01888900 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-02-07

Study results available
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Summary

Background:

\- Some people who have chronic hepatitis C do not respond to the usual treatment with peginterferon and ribavirin. New chronic hepatitis treatments are being developed that may work better for different people. The treatments will look at how specific genes interact with the drugs. Researchers want to see how well these new drugs work in people whose chronic hepatitis C has not responded or only partly responded to the usual treatment drugs.

Objectives:

\- To compare new treatments for people with chronic hepatitis C.

Eligibility:

\- Individuals at least 18 years of age who have chronic hepatitis C that has not responded to standard treatments.

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Liver scans and a biopsy will be taken before the start of treatment.
* Participants will be separated into two groups. One group will have the new treatment drugs (assunaprevir and daclatasvir). The second group will have these two drugs as well as peginterferon and ribavirin. All participants will have an initial 4-day hospital stay with regular blood tests to see how the start of the treatment works.
* The first group will take the new study drug tablets daily for 24 weeks. Those who do not respond to this treatment will also start to take peginterferon and ribavirin, and the treatment will continue for 24 weeks after starting the additional drugs.
* The second group will take all four drugs according to the standard dosing schedule for 24 weeks.
* Treatment will be monitored with frequent blood tests. Liver scans, biopsies, and other tests will be performed as directed by the study doctors.
* Participants will have 24 weeks of regular followup visits.

Conditions

  • Cirrhosis
  • Chronic Hepatitis C
  • Hepatitis C
  • Hepatitis C, Chronic

Interventions

DRUG

DUAL

Asunaprevir and Daclatsvir

DRUG

QUAD

Asunaprevir, daclatsvir, peginterferon and ribavirin

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Marc G Ghany, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01888900 on ClinicalTrials.gov