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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00863109 |
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 |
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Hepatitis C, Chronic Genotype 1 HCV-1 |
Biological: Peginterferon alfa-2b Drug: Ribavirin |
Study Type: | Observational |
Study Design: | Cohort, 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. |
Estimated Enrollment: | 238 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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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.
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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. 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 |
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.
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:
Exclusion Criteria:
Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group ( Schering-Plough ) |
Study ID Numbers: | P05278 |
Study First Received: | March 12, 2009 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00863109 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Antimetabolites Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human Quality of Life Antiviral Agents |
Hepatitis Virus Diseases Digestive System Diseases Peginterferon alfa-2b Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic Interferon Alfa-2b |
Antimetabolites Anti-Infective Agents Liver Diseases RNA Virus Infections Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Flaviviridae Infections Ribavirin Hepatitis, Viral, Human |
Antiviral Agents Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Therapeutic Uses Peginterferon alfa-2b Hepatitis C Hepatitis C, Chronic |