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Sponsors and Collaborators: |
ViroChem Pharma Duke University |
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Information provided by: | ViroChem Pharma |
ClinicalTrials.gov Identifier: | NCT00623649 |
The purpose of this study is to determine whether a 3-day course of therapy with orally administered VCH-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of treatment with VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma at various time points during the treatment period.
Condition | Intervention | Phase |
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HCV Infection |
Drug: VCH 916 Drug: Placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment |
Official Title: | A Phase IB, Multicentre, Randomized, Double-Blinded, and PLacebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and PK of Multiple Ascending Doses of VCH-916 in the Treatment Naive or Experienced Subjects With Chronic Hep C-Infection. |
Estimated Enrollment: | 55 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cohort 1 to 4: Experimental
This will be a 4 doses escalation study comparing VCH 916 to Placebo treatment.
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Drug: VCH 916
Dose escalation study with a full review of all safety data following each cohort.
Drug: Placebo
Dose escalation study with a full review of all safety data following each cohort.
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: John McHutchison, MD | 919-668-7177 | mchut001@mc.duke.edu |
United States, Florida | |
Center for Liver Diseases, Miller School of Medicine, University of miami | Not yet recruiting |
Miami, Florida, United States, 33136 | |
Contact: Chakradhar Reddy, MD 305-243-4615 chakram_reddy@hotmail.com | |
Principal Investigator: Chakradhar Reddy, MD | |
United States, Texas | |
Alamo Medical Research | Recruiting |
San Antonio, Texas, United States, 78215 | |
Contact: Eric Lawitz, MD 210-253-3426 ext 261 lawitz@alamomedicalresearch.com | |
Principal Investigator: Eric Lawitz, MD | |
The Liver INstitute at Methodist Dallas | Recruiting |
Dallas, Texas, United States, 75208 | |
Contact: Reem Ghalib, MD 214-947-4449 reemghalib@mhd.com | |
Principal Investigator: Reem Ghalib, MD | |
Canada, Ontario | |
Ottawa Hospital - General Campus | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Curtis Cooper, MD 613-737-8924 ccooper@ottawahospital.on.ca | |
Principal Investigator: Curtis Cooper, MD | |
Canada, Quebec | |
Royal Victoria Hospital | Recruiting |
Montréal, Quebec, Canada, H3A 1A1 | |
Contact: Richard Lalonde, MD 514-934-1934 ext 36347 richard.lalonde@muhc.mcgill.ca | |
Principal Investigator: Richard Lalonde, MD | |
Puerto Rico | |
Fundacion de Investigacion de Diego | Recruiting |
Santurce, Puerto Rico, 00909 | |
Contact: Maribel Rodriguez-Torres, MD 787-722-1248 rodztorres@coqui.net | |
Principal Investigator: Maribel Rodriguez-Torres, MD |
Principal Investigator: | John McHutchison, MD | Duke University |
Responsible Party: | ViroChem Pharma Inc. ( Louise Proulx, Vice President Product Development ) |
Study ID Numbers: | VCH 916-103 |
Study First Received: | February 14, 2008 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00623649 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Antiviral Agents |
Communicable Diseases Infection |