Quality of Life in Chronic Hepatitis C (Study P05278) (VIDA)
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Purpose
As widely shown in previous reports HCV patients commonly experience fatigue, anxiety, and depression. These symptoms negatively affect patients' functional health, ability to work, self-perceived health, HRQL and well-being. Psychosocial issues and reduced HRQL are frequently experienced by HCV patients (4-6). HCV patients have more HRQL impairment than the general population (4, 5, 7-9). There is some evidence that HCV patients who experience greater fatigue, greater psychiatric symptoms, and poorer HRQL are more likely to discontinue treatment prematurely with its negative impact on virological response (10, 11). In addition to well-known side effects of interferon, one important determinant of HRQL during anti-viral therapy for HCV is development of ribavirin-induced anemia (12-16). Treatment of anemia improves HRQL, potentially impacting adherence to antiviral regimen and improving virologic response (21). These issues emphasize the importance of investigating the physical and psychosocial experiences and HRQL of HCV patients.
| Condition | Intervention |
|---|---|
|
Hepatitis C, Chronic Genotype 1 HCV-1 |
Biological: Peginterferon alfa-2b Drug: Ribavirin |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pharmacist Assessment of Peginterferon Based Therapies on Health Related Quality of Life in Patients Genotype 1 With Chronic Hepatitis C in Spanish Standard Clinical Practice. |
- To assess the changes in QOL of patients during all standard Hepatitis C treatment phases and establish the relationship between these changes and treatment response as well as identify the factors that can be involved in these changes in HRQOL. [ Time Frame: Baseline, weeks 4, 12, 24 & 48 of treatment and at follow-up 4 and 24 weeks after cessation of treatment, according genotype and standards clinical practices. ] [ Designated as safety issue: No ]
- The mean variable to be used to calculate sample size has been selected as vitality because this is the score into the HRQOL questionnaires which varies more after and before treatment (described into sample size and biostatistical frames). [ Time Frame: Baseline, weeks 4, 12, 24 & 48 of treatment and at follow-up 4 and 24 weeks after cessation of treatment, according genotype and standards clinical practices. ] [ Designated as safety issue: No ]
- To identify the factors that can be involved in such these changes of HRQOL. to identify which factors related to clinical Pharmacist may improve the adherence to treatment and quality of life of patients with Chronic Hepatitis C. [ Time Frame: Baseline, weeks 4, 12, 24 & 48 of treatment and at follow-up 4 and 24 weeks after cessation of treatment, according genotype and standards clinical practices. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 238 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients with Chronic Hepatitis C, Genotype 1
Patients with Chronic Hepatitis C, Genotype 1, no other co-infection and compensated liver disease who receive peginterferon α-2b and ribavirin in combination therapy according to standard clinical practice.
|
Biological: Peginterferon alfa-2b
The Pharmacist at the Hospital will offer the HRQOL to the patients who attend the Pharmacy sites to receive the pegylated interferon alfa-2b in combination with ribavirin treatment previously prescribed by the Doctor according to the standard clinical practice. Doses and regimen of treatment will be determined by the Doctor as per standard prescribed doses and duration of therapy, not by the Pharmacist. Other Names:
Drug: Ribavirin
The Pharmacist at the Hospital will offer the HRQOL to the patients who attend the Pharmacy sites to receive the pegylated interferon alfa-2b in combination with ribavirin treatment previously prescribed by the Doctor according to the standard clinical practice. Doses and regimen of treatment will be determined by the Doctor as per standard prescribed doses and duration of therapy, not by the Pharmacist Other Names:
|
Detailed Description:
The sample size of the study must allow evaluating HRQoL of C hepatitis patients based on the SF-36 questionnaire before PegIntron treatment and at each of the following study visits.
Spiegel et al. performed a systematic review of HRQoL and C hepatitis concluding that the vitality dimension was the most important dimension of the SF-36 questionnaire in this type of patients. Spiegel also concluded that the MCID in the vitality dimension was 4.2 points.
The study performed by Dan et al. in patients with chronic C hepatitis, showed a mean (SD) of 61.8 (22.6) points in men and 54 (22.8) points in women in the vitality dimension of the SF-36. To be able to detect differences of or over 4.2 points in this dimension between the basal visit and following visits, estimating a SD of 22 points, a statistical power of 80%, and a level of significance of 0,05, 216 will be needed.
Considering a loss of follow up of 15%, a total of 238 patients will be included in the study.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with Chronic Hepatitis C, Genotype 1, no other co-infection and compensated liver disease who receive peginterferon α-2b and ribavirin in combination therapy according to standard clinical practice.
Inclusion Criteria:
- Available to understand and to give Informed consent.
- Genotype 1.
- HCV positive patients by HCV-RNA PCR (limit of detection of the assay < 50IU/ml)
- Compensated Liver disease.
- Naïve patients that undergoing treatment with Peginterferon alfa-2b + ribavirin according to standard of care
- Age between 18-65 years
- Patients who comes to Pharmacy site to receive their supplies for hepatitis C treatment after Physician prescription.
Exclusion Criteria:
- Women of childbearing potential (ie, premenopausal women and women who are less than 6 months postmenopausal) who will not use an appropriate contraceptive method during the course of the clinical study. Appropriate contraceptives include double barrier methods (eg, diaphragm or condom plus spermicide), intrauterine device, oral, injectable or subcutaneous hormonal contraceptive, or surgically sterilized partner.
- Patients who completed treatment with peginterferon alfa-2b plus ribavirin more than 4 weeks before study entry.
- Patients with positive HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
- Patients treated for a period shorter than the enrollment period.
- Patients coinfected with HIV.
- Patients coinfected with HBV.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00863109 History of Changes |
| Other Study ID Numbers: | P05278 |
| Study First Received: | March 12, 2009 |
| Last Updated: | June 11, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Ribavirin Peginterferon alfa-2b Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013