Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-02-28 @ 8:19 AM
Study NCT ID:
NCT02932293
Status:
WITHDRAWN
Last Update Posted:
2017-05-12
First Post:
2016-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triple Combination DAAs for Treating HCV GT1b Subjects
Sponsor:
Humanity and Health Research Centre
Organization:
Study Overview
Official Title:
Triple Combination DAAs for Ultra Short Duration Therapy for HCV Genotype 1b in Chinese (SODAPI II Study)
Status:
WITHDRAWN
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The collaborating pharmaceutical company will not wish to continue with the trial due to the internal issues in the company.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg) in this study but the treatment duration may be different depending on patients' response to the antiviral therapy and whether patients have liver cirrhosis. If patients have no cirrhosis and the HCV viral load on day 2 is \<500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If patients have cirrhosis and the HCV viral load on day 2 is \<500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be 8 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: