Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C
NCT00120835 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2010-06-10
Summary
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.
Conditions
- Chronic Hepatitis C
Interventions
- DRUG
-
valopicitabine
- DRUG
-
pegylated interferon
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-07-31
Countries
- United States
- Puerto Rico
Study Locations
More Related Trials
-
Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)
NCT00774397 ·Status: COMPLETED ·Phase: PHASE2
-
A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment
NCT00980330 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)
NCT01297270 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of TMC435350 Administered With or Without Standard of Care Therapy in Participants With Genotype 1 Hepatitis C Virus Infection
NCT00561353 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
NCT00793793 ·Status: COMPLETED ·Phase: PHASE1
-
Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C
NCT00227435 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment
NCT00882908 ·Status: COMPLETED ·Phase: PHASE2
-
Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
NCT01859962 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection
NCT01608737 ·Status: WITHDRAWN ·Phase: PHASE3
-
CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Relapsed Hepatitis C Virus (HCV) Subjects
NCT00142103 ·Status: COMPLETED ·Phase: PHASE1
-
TMC435350-TiDP16-C101 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of Increasing Oral Doses of TMC435350 After Single and Repeated Dosing
NCT00938899 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients
NCT00947349 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, PK and Efficacy of 15 Days of SCY-635 Treatment in Hepatitis C Patients
NCT01290965 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1)
NCT01343888 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
NCT01846832 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy
NCT01281839 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Nitazoxanide in the Treatment of Chronic Hepatitis C
NCT00418639 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluating the Safety of ITX 5061 in Treatment-Naive Hepatitis C (HCV)-Infected Adults
NCT01165359 ·Status: COMPLETED ·Phase: PHASE1
-
4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C
NCT00763568 ·Status: COMPLETED ·Phase: PHASE2
-
CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
NCT00277238 ·Status: COMPLETED ·Phase: PHASE2
-
The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
NCT00001035 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects
NCT01473056 ·Status: COMPLETED ·Phase: PHASE1
-
An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients
NCT01725529 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive
NCT00093093 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C
NCT01903954 ·Status: COMPLETED ·Phase: PHASE2