Observational,Prospective Study to Develop and Validate a Prognostic Tool to Optimize Therapy in Patients With HCV G1/4
OPTIM
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.
1 other identifier
observational
770
1 country
2
Brief Summary
Primary objective: • Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 18, 2013
CompletedFirst Posted
Study publicly available on registry
June 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedSeptember 4, 2014
September 1, 2014
3.6 years
June 18, 2013
September 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained Viral Response (RVS)
Measurement of HCV RNA negativization 24 weeks after treatment
1 ½ years (72 weeks)
Study Arms (1)
Pegasys, injection subcutaneous
HCV patients monoinfected or coinfected genotype 1/4 treated with Peginterferon alfa-2a and Ribavirin
Interventions
Treatment as usual clinical practice
Treatment as usual clinical practice
Eligibility Criteria
Patients with chronic hepatitis C genotype 1 and 4 mono-or co-infected with HIV who meet the selection criteria described.
You may qualify if:
- 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 who have accepted their participation in the study through informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)
Seville, Sevilla, Spain
Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)
Seville, Spain
Biospecimen
Whole blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manuel Romero-Gómez, Medicine
Hospital de Valme & ciberEHD
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2013
First Posted
June 24, 2013
Study Start
October 1, 2010
Primary Completion
May 1, 2014
Study Completion
August 1, 2014
Last Updated
September 4, 2014
Record last verified: 2014-09