Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 75 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01884402
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : September 4, 2014
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary:

Primary objective:

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


Condition or disease Intervention/treatment
Hepatitis C, Chronic Drug: Peginterferon alfa-2a Drug: Ribavirin

Detailed Description:

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 770 participants
Time Perspective: Prospective
Official Title: Observational,Post-authorization Prospective Study to Develop and Validate a Prognostic Tool for Optimizing Therapy in Patients With Hepatitis C Virus (HCV) Genotype 1 and 4.
Study Start Date : October 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pegasys, injection subcutaneous
HCV patients monoinfected or coinfected genotype 1/4 treated with Peginterferon alfa-2a and Ribavirin
Drug: Peginterferon alfa-2a
Treatment as usual clinical practice
Other Name: Pegasys

Drug: Ribavirin
Treatment as usual clinical practice
Other Name: Copegus




Primary Outcome Measures :
  1. Sustained Viral Response (RVS) [ Time Frame: 1 ½ years (72 weeks) ]
    Measurement of HCV RNA negativization 24 weeks after treatment


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic hepatitis C genotype 1 and 4 mono-or co-infected with HIV who meet the selection criteria described.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884402


Locations
Layout table for location information
Spain
Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)
Sevilla, Spain
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
Layout table for investigator information
Principal Investigator: Manuel Romero-Gómez, Medicine Hospital de Valme & ciberEHD

Layout table for additonal information
Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT01884402     History of Changes
Other Study ID Numbers: FPS-PEG-2010-01
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Virus Diseases
RNA Virus Infections
Peginterferon alfa-2a
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents