Ignite Creation Date:
2024-05-06 @ 2:30 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02057887
Status:
UNKNOWN
Last Update Posted:
2014-02-07
First Post:
2013-08-08
Brief Title:
SafetyTolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients HM10660A
Sponsor:
Hanmi Pharmaceutical Company Limited
Organization:
Hanmi Pharmaceutical Company Limited
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2014-02
Last Known Status:
RECRUITING
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 purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis CHCV
Detailed Description:
To evaluate the repeat-dose pharmacokinetics PK of HM10660A when given by weekly biweekly and monthly subcutaneous SC injection
To evaluate the repeat-dose pharmacodynamics PD of HM10660A when given by weekly biweekly and monthly SC injection
To explore the antiviral activity of HM10660A at Week 4 Week 12 and Week 24
To evaluate the repeat-dose pharmacodynamics PD of HM10660A when given by weekly biweekly and monthly SC injection
To explore the antiviral activity of HM10660A at Week 4 Week 12 and Week 24
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