Chronic Hepatitis C Clinical Trial
Official title:
A Phase IIa Safety Study of Oral Administration of Anti-CD3 Monoclonal Antibody in Non-responder Genotype-I Chronic Hepatitis C Subjects, a Single-blind, Randomized, Controlled Multi-center Study.
The use of oral aCD3 Monoclonal antibody (MAb) alone in subjects with hepatitis C is justified on the basis of scientific and medical reasons. There are data in multiple animal models that aCD3-alone confers efficacy in models of inflammatory or autoimmune disease and induces regulatory T cells and immune-modulation as desired in clinical studies. These observations are reinforced by data in the Phase 1 clinical study showing that aCD3-alone induced the desired immune-modulation in terms of immunological markers for regulatory T cells and appropriate rises and declines in certain cytokine levels.
Oral aCD3 MAb will be administered at a dosage level of 0.2 or 1.0 or 5.0 mg per day for 30 days. Up of 9 subjects will be treated at each dosage level, and up to 9 subjects will receive placebo buffered in normal saline that is used as diluents for the MAb. One 20mg tablet of Omeprazole (a proton pump inhibitor) will be taken orally as part of the study drug cocktail in order to neutralize stomach pH for enhancing stability of the MAb. During the treatment period, subjects will ingest the study drug/s every day for 30 days, and will be followed for clinical and laboratory effects. Subjects will be followed up to Day 60 (30 days after termination of treatment) ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01937975 -
The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)
|
Phase 1 | |
| Completed |
NCT03673696 -
The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT02250001 -
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
|
N/A | |
| Completed |
NCT03088917 -
'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'
|
||
| Completed |
NCT02207088 -
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
|
Phase 3 | |
| Not yet recruiting |
NCT02865369 -
Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment
|
N/A | |
| Recruiting |
NCT02638233 -
Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy
|
Phase 4 | |
| Not yet recruiting |
NCT02511496 -
Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia
|
N/A | |
| Not yet recruiting |
NCT01949168 -
A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV
|
Phase 2 | |
| Completed |
NCT02788682 -
Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy
|
N/A | |
| Completed |
NCT01439776 -
Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients
|
Phase 4 | |
| Recruiting |
NCT01360879 -
Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
|
N/A | |
| Recruiting |
NCT01360892 -
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography
|
N/A | |
| Terminated |
NCT00962936 -
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
|
Phase 1/Phase 2 | |
| Completed |
NCT00968357 -
Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed
|
Phase 2 | |
| Recruiting |
NCT01178749 -
Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments
|
N/A | |
| Recruiting |
NCT00575627 -
Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels
|
Phase 4 | |
| Completed |
NCT00537407 -
A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment
|
Phase 2 | |
| Recruiting |
NCT00370617 -
Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance
|
Phase 4 | |
| Completed |
NCT01684787 -
Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients
|
Phase 4 |