Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081770
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2004-04-20
Brief Title:
Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 Study P03471
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Comparison of PEG-Intron 15µgkgwk Plus REBETOL vs PEG-Intron 1µgkgwk Plus REBETOL vs PEGASYS 180µgwk Plus COPEGUS in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected With Genotype 1
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1 1 PegIntron 15 µgkgwk in combination with weight based REBETOL 800-1400 mgday 2 PegIntron 1µgkgwk in combination with weight based REBETOL 800-1400 mgday and 3 PEGASYS 180 µgwk plus COPEGUS 1000-1200 mgday
Detailed Description:
PegIntron Dose will be administered once weekly subcutaneously on the same day of the week
Screening 2 Weight 40-50 kg Volume to Inject mL 022 Screening 2 Weight 51-60 kg Volume to Inject mL 028 Screening 2 Weight 61-75 kg Volume to Inject mL 033 Screening 2 Weight 76-85 kg Volume to Inject mL 041 Screening 2 Weight 86-104 kg Volume to Inject mL 048 Screening 2 Weight 105-125 kg Volume to Inject mL 058 from two vials
REBETOL Dosage for Use With PegIntron
Screening 2 Weight 40-65 kg Daily Dose 800 mg Screening 2 Weight 65-85 kg Daily Dose 1000 mg Screening 2 Weight 85-105 kg Daily Dose 1200 mg Screening 2 Weight 105-125 kg Daily Dose 1400 mg
The PEGASYS dose of 1 mL 180 µg will be administered once weekly subcutaneously on the same day of the week
COPEGUS Dosage for Use With PEGASYS
Screening 2 Weight 75 kg Daily Dose 1000 mg Screening 2 Weight or 75 kg Daily Dose 1200mg
NOTE Double Blind for PegIntron Open Label for REBETOL PEGASYS and COPEGUS
NOTE REBETOL is the Schering-Plough brand name for ribavirin COPEGUS is the Hoffman-La Roche brand name for ribavirin
Screening 2 Weight 40-50 kg Volume to Inject mL 022 Screening 2 Weight 51-60 kg Volume to Inject mL 028 Screening 2 Weight 61-75 kg Volume to Inject mL 033 Screening 2 Weight 76-85 kg Volume to Inject mL 041 Screening 2 Weight 86-104 kg Volume to Inject mL 048 Screening 2 Weight 105-125 kg Volume to Inject mL 058 from two vials
REBETOL Dosage for Use With PegIntron
Screening 2 Weight 40-65 kg Daily Dose 800 mg Screening 2 Weight 65-85 kg Daily Dose 1000 mg Screening 2 Weight 85-105 kg Daily Dose 1200 mg Screening 2 Weight 105-125 kg Daily Dose 1400 mg
The PEGASYS dose of 1 mL 180 µg will be administered once weekly subcutaneously on the same day of the week
COPEGUS Dosage for Use With PEGASYS
Screening 2 Weight 75 kg Daily Dose 1000 mg Screening 2 Weight or 75 kg Daily Dose 1200mg
NOTE Double Blind for PegIntron Open Label for REBETOL PEGASYS and COPEGUS
NOTE REBETOL is the Schering-Plough brand name for ribavirin COPEGUS is the Hoffman-La Roche brand name for ribavirin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2552898 | None | None | None |