Chronic Hepatitis C Clinical Trial
Official title:
Efficacy and Safety of Continuing for a Total of 48 or Prolonging for a Total of 72 Weeks of Combined Treatment of Patients Receiving Pegasys and Copegus Who Are Biochemical Responders But Virological Non-Responders at Week 12 or Week 24
Primary objective is to measure sustained viral response given to continuation or
prolongation of combined Pegasys&Copegus treatment
Secondary objective is to measure histological response given to continuation or
prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods
Prospective, multicentre, randomized, open-label comparative study
According to our national guideline of management of patient with chronic viral hepatitis,
patients need to stop therapy if they do not achieve response.
These patients can enter to the study at two time points:
- at week 16, if HCV RNS PCR measured at week 12 is positive and serum ALT > 1ULN, but
decreased
- at week 28, if HCV RNS PCR measured at week 24 is still positive, but serum ALT < 2ULN.
Patients are randomized to one of the following arms:
- S (standard) group: Pegasys&Copegus combined therapy 180 mcg/week & weight/based
1000-1200 mg/day for a total of 48 weeks of treatment
- P (prolonged) group: Pegasys&Copegus combined therapy 180 mcg/week & -weight/based
1000-1200 mg/day for a total of 72 weeks of treatment.
After completing treatment period patients enter into a 24-week follow up.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy 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 | |
| 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 | |
| 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 | |
| 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 |