Quality of Life in Chronic Hepatitis C (Study P05278) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00863109

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:	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.

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2b

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
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. 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

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.

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

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

Study Population

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.

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863109

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Spain
Coordinating Location	Recruiting
Madrid, Spain

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group ( Schering-Plough )
Study ID Numbers:	P05278
Study First Received:	March 12, 2009
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00863109 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Antimetabolites
Interferon-alpha
Anti-Infective Agents
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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 11, 2009