Observational,Prospective Study to Develop and Validate a Prognostic Tool to Optimize Therapy in Patients With HCV G1/4

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

770 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Primary objective:

• Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Observational Study of Peginterferon Alfa-2a in Combination With Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis

NCT01609049

Hepatitis C, Chronic

COMPLETED

Antiviral Therapy in Decompensated Hepatitis C Virus (HCV) Cirrhosis

NCT00301509

Liver Cirrhosis, Experimental

COMPLETED PHASE2/PHASE3

Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED)

NCT00724373

Hepatitis C, Chronic

COMPLETED

Viral Kinetics and Liver Gene Expression in Response to Ribavirin and Peginterferon Therapy of Chronic Hepatitis C

NCT00718172

Hepatitis C, Chronic

COMPLETED PHASE1

Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)

NCT00709059

Hepatitis C, Chronic

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This Tool:

1. Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR).
2. Identify those patients most likely to respond.
3. Therapy and therefore optimize resources

The validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pegasys, injection subcutaneous

HCV patients monoinfected or coinfected genotype 1/4 treated with Peginterferon alfa-2a and Ribavirin

Peginterferon alfa-2a

Intervention Type DRUG

Treatment as usual clinical practice

Ribavirin

Intervention Type DRUG

Treatment as usual clinical practice

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peginterferon alfa-2a

Treatment as usual clinical practice

Intervention Type DRUG

Ribavirin

Treatment as usual clinical practice

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pegasys Copegus

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with \> 18 years old.
* Patients diagnosed with chronic hepatitis C in the presence of HCV RNA in plasma that meet criteria for initiating antiviral therapy in routine clinical practice conditions.
* Patients Genotype 1 and 4.
* Patients with the results of all the factors evaluable at the time of inclusion.
* Patients who have accepted their participation in the study through informed consent.

Exclusion Criteria

* Patients previously treated with interferon (IFN) and ribavirin (RBV).
* Patients with genotype 2, 3, 5 and 6.
* Patients with co-infection with hepatitis B.
* Patients with other liver diseases.
* Patients with any contraindications to the drugs used in the treatment of hepatitis C.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No