NCT00124215已完成1 期
A Phase 1 Double-Blind, Placebo Controlled, Dose-Escalation, Multi-center Therapeutic Trial of the Safety, Immunogenicity, and Efficacy of GI-5005; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, in Patients With Chronic Hepatitis C Infection
GlobeImmune10 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2005年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 10
- 主要终点
- Safety and tolerability
研究概览
简要总结
The GI-5005 therapeutic vaccine or placebo will be injected under the skin of hepatitis C virus (HCV) subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic hepatitis C virus infection including treatment naive subjects as well as subjects who are partial responders and relapsers to prior interferon therapy
- •>18 years of age
- •Negative skin test for hypersensitivity to saccharomyces cerevisiae.
排除标准
- •Non-responders to previous interferon treatments
- •Cirrhosis
- •HCV treatment within 3 months
- •Hepatitis B infection
- •HIV infection
结局指标
主要结局
Safety and tolerability
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (10)
Loading locations...
相似试验
已完成
1 期
Phase I/II clinical trials using hepatitis C virus peptide with the combination therapy of interferon and ribavirin for the patient with chronic hepatitis Cchronic hepatitis CJPRN-UMIN000002601Ehime University Graduate School of Medicine, Department of Gastroenterology and Metabology20
Unknown
1 期
Therapeutic Hepatitis C Virus VaccineChronic Hepatitis C InfectionNCT04318379GeneCure Biotechnologies30
终止
1 期
TMC649128HPC1002 - a Trial inGenotype 1 Hepatitis C Virus (HCV) - Infected Participants to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of TMC649128, Alone and Combined With Pegylated Interferon + RibavirinHepatitis C VirusNCT01391117Tibotec BVBA14
已完成
1 期
Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant RecipientsEvidence of Liver TransplantationHepatitis CNCT01292824University of Birmingham24
已完成
1 期
Staged Phase I/II Hepatitis C Prophylactic VaccineHepatitis CNCT01436357National Institute of Allergy and Infectious Diseases (NIAID)548