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Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Chronic Hepatitis C

Treatments

Drug: pegylated interferon
Drug: valopicitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00120835
NV-08A-003

Details and patient eligibility

About

This study is being conducted in treatment-naive patients (no previous hepatitis C treatment) to evaluate the safety of valopicitabine (NM283) alone and together with pegylated interferon, a drug approved by the Food and Drug Administration for the treatment of hepatitis C infection. This study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis C virus in the body. The results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Documented clinical history compatible with genotype-1, chronic hepatitis C infection
  • Treatment-naive (patient has received no previous therapy for hepatitis C viral infection)

Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Patient is pregnant
  • Patient is co-infected with hepatitis B or HIV

Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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