Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774107
Status:
COMPLETED
Last Update Posted:
2022-08-30
First Post:
2021-01-21
Brief Title:
The Pharmacokinetics of P1101 Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus HCV Genotype 2 Infection
Sponsor:
PharmaEssentia
Organization:
PharmaEssentia
Study Overview
Official Title:
An Open-label Study to Assess the Pharmacokinetics of P1101 Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis With HCV Genotype 2 Infection
Status:
COMPLETED
Status Verified Date:
2022-08
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:
Primary Objective
To determine the P1101 pharmacokinetic PK profile at the single dose of 400 μg
To determine the P1101 pharmacokinetic PK profile at the single dose of 400 μg
Detailed Description:
Secondary Objective
To determine the safety and immunogenicity of P1101 400 μg subcutaneous SC single dose Ribavirin 800-1400 mg PO daily
To determine the safety and immunogenicity of P1101 400 μg subcutaneous SC single dose Ribavirin 800-1400 mg PO daily
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None