Quality of Life in Chronic Hepatitis C (Study P05278) (VIDA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00863109
First received: March 12, 2009
Last updated: August 9, 2013
Last verified: August 2013
  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.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Enrollment: 133
Study Start Date: April 2009
Study Completion Date: May 2013
Primary Completion Date: May 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:
  • PegIntron
  • SCH 54031
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:
  • Rebetol
  • SCH 18908

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00863109     History of Changes
Other Study ID Numbers: P05278
Study First Received: March 12, 2009
Last Updated: August 9, 2013
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 April 21, 2014