| |
New Pegasys Study for HCV+ Untreated Patients with Genotype 1, High Weight & High Viral Load
|
| |
| |
"Pegasys in Combination with Copegus in Previously Untreated Patients with Chronic Hepatitis C Genotype 1 of High Viral Count and Body Weight > 85 kg (187 lbs)"
Source: www.clinicaltrials.gov
This study is currently recruiting patients.
Sponsored by Hoffmann-La Roche
Purpose of The Study
The objective of this study is to evaluate the effects of higher doses of Pegasys and Copegus in patients infected with Hepatitis C, whose body weight is greater than 85 kg (187 lbs) and who have a high viral count.
CONDITION: Chronic Hepatitis C
TREATMENT DRUGS: Pegylated Interferon alfa-2a in combination with Ribavirin
Phase IV Study
Official Title: Evaluation of the effect of Pegasys doses of 180 ug or 270 ug in combo w/ Copegus doses of 1200 mg or 1600 mg in previously untreatedpatients w/ Chronic Hepatitis C Genotype 1 of high viral count and body wt greater than 85 kg (187 lbs)
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
--Age greater than or equal to 18 years
--Infected with Hepatitis C virus Genotype 1
--High Viral Count (HCV RNA count greater than 800,000 IU/mL)
--Body Weight greater than 85 kg (187 lbs)
Exclusion Criteria:
--Pregnant, breast-feeding or male partners of those who are pregnant
--Infection with Hepatitis C virus Genotype 2, 3, 4, 5, 6 or undetermined
--Previously treated with interferon, pegylated interferon, ribavirin, viramidine, levovirin or amantadine at any previous time or any other systemic antiviral therapy or investigational drug less than or equal to 3 months prior to first dose of study drug. Exception: Patients with a limited (less than or equal to 7 day) course of acyclovir or valacyclovir for herpes more than 1 month prior to first dose of study drug are not excluded.
Study Locations and Contact Information
Please reference Study ID Number: PDO-NV17318 973-235-5000 (Roche tel#)or 800-526-6367 (FOR US ONLY)
California
San Diego, California, 92120, United States; Recruiting
(619) 563-4040
Long Beach, California, 90822, United States; Recruiting
(562) 826-5933
La Jolla, California, 92037, United States; Recruiting
(858) 554-8097
Downey, California, 90242, United States; Completed
Connecticut
Farmington, Connecticut, 06030, United States; Recruiting
(860) 679-8156
(860) 679-3749
Florida
Gainesville, Florida, 32610-0214, United States; Recruiting
(352) 392-7956
(352) 392-5454
Jacksonville, Florida, 32207, United States; Recruiting
(904) 680-0871
Wellington, Florida, 33414, United States; Not yet recruiting
Bradenton, Florida, 34205, United States; Recruiting
(941) 746-2711
Hawaii
Honolulu, Hawaii, 96817, United States; Recruiting
(808) 547-6541
Illinois
Chicago, Illinois, 60612, United States; Recruiting
(312) 563-3903
Indiana
Indianapolis, Indiana, 46214-2985, United States; Completed
Iowa Iowa City, Iowa, 52242, United States; Recruiting
(319) 356-1660
Massachusetts
Boston, Massachusetts, 02111, United States; Recruiting
(617) 636-4532
Boston, Massachusetts, 02114, United States; Terminated
Minnesota
Plymouth, Minnesota, 55446, United States; Terminated
Missouri
St. Louis, Missouri, 63104, United States; Recruiting
New Jersey
Princeton, New Jersey, 08540-6233, United States; Completed
New York
Manhasset, New York, 11030, United States; Not yet recruiting
(516) 562-4281
North Carolina
Chapel Hill, North Carolina, 27599-7080, United States; Recruiting
(919) 966-6732
Charlotte, North Carolina, 28203, United States; Recruiting
Ohio
Cincinnati, Ohio, 45267, United States; Recruiting
(513) 584-5245
Pennsylvania
Philadelphia, Pennsylvania, 19104, United States; Not yet recruiting
Pittsburgh, Pennsylvania, 15213, United States; Recruiting
(412) 647-1462
(412) 647-1170
Texas
Houston, Texas, 77030, United States; Not yet recruiting
Utah
Salt Lake City, Utah, 84121, United States; Recruiting
(801) 944-3165
Virginia Richmond, Virginia, 23249, United States; Recruiting
(804) 675-5021
Charlottesville, Virginia, 22906-0013, United States; Not yet recruiting
(434) 924-2626
Canada, Ontario
Toronto, Ontario, M5G 1L7, Canada; Terminated
Puerto Rico
Santurce, 00909, Puerto Rico; Recruiting
(787) 722-1248
More Information
Study ID Numbers NV17318
Record last reviewed May 2004
NLM Identifier NCT00077649
ClinicalTrials.gov processed this record on 2004-06-04
|
|
| |
| |
|
|
|
