Hepatitis C, ChronicVIDANCT00863109

Quality of Life During Treatment of Chronic Hepatitis C (P05278/MK-4031-336)

An observational study of Hepatitis C, Chronic and Genotype 1, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to evaluate the impact of chronic hepatitis C (CHC), and the treatment thereof with peginterferon alpha-2b (PEG) and ribavirin (RBV) according to standard clinical practice, on the health-related quality of life (HRQL) of a cohort of participants throughout 72 weeks of follow-up. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic, Genotype 1, HCV-1
What is being tested?: Peginterferon alfa-2b (PEG) and Ribavirin (RBV)
How many people: 133 participants
Where: No sites listed yet
Study dates: Apr 2009to May 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants with Chronic Hepatitis C, Genotype 1, no other co-infection and compensated liver disease who receive PEG and RBV in combination therapy according to standard clinical practice.

Who may be able to join

Participants diagnosed with chronic hepatitis C (CHC)
Participants with HCV genotype 1
Participants who, at the time of the study, are referred to the Hospital Pharmacy Service to begin treatment with PEG and RBV for 48 weeks
Available to understand and to give Informed Consent

Who cannot join

Participants co-infected with Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)

About this study

Official title: Evaluation of the Health-Related Quality of Life During Combined Treatment of Chronic Hepatitis Due to Hepatitis C Virus Under Habitual Clinical Practise Conditions.

Read the detailed description

As widely shown in previous reports Hepatitis C Virus (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. HCV patients have more HRQL impairment than the general population. 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 a negative impact on virological response. In addition to well-known side effects of interferon, one important determinant of HRQL during anti-viral therapy for HCV is development of RBV-induced anemia. Treatment of anemia improves HRQL, potentially impacting adherence to antiviral regimen and improving virologic response. These issues emphasize the importance of investigating the physical and psychosocial experiences and HRQL of HCV patients.

The sample size of the study must allow evaluating HRQL of HCV patients based on the SF-36 before PEG treatment and at each of the following study visits.

To be able to detect differences of or over 4.2 points in the vitality dimension between the basal visit and following visits, estimating a standard deviation of 22 points, a statistical power of 80%, and a level of significance of 0.05, 216 patients will be needed. Considering a loss of follow up of 15%, a total of 238 patients are planned for this study.

Conditions: Hepatitis C, Chronic, Genotype 1, HCV-1
Being tested: Peginterferon alfa-2b (PEG), Ribavirin (RBV)
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peginterferon alfa-2b (PEG)Biological
Also called PegIntron, SCH 054031
Pegylated interferon alfa-2b was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).
Ribavirin (RBV)Drug
Also called Rebetol, SCH 18908
Ribavirin was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).

Study groups in NCT00863109
Study group	Role	What they receive
PEG + RBV (Standard Clinical Practice)		Participants receive peginterferon alfa-2b (PEG) and ribavirin (RBV) in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation. Receives: Biological: Peginterferon alfa-2b (PEG); Drug: Ribavirin (RBV)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores
SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.
Measured: Baseline, Week 72
Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)
The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life.
Measured: Baseline, Week 72

Secondary outcomes (5)

Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)
SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.
Measured: Baseline, Week 72
Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)
The CLDQ-HCV is a disease-specific questionnaire measuring quality of life that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life.
Measured: Baseline, Week 72
Minimal Clinically Important Difference (MCID) in SF-36 Scores
SF-36 is a 36-item questionnaire measuring HRQL covering 2 summary measures, PCS and MCS. The SF-36 consists of 8 subscales. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst HRQL, 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status as perceived by themselves). The MCID was calculated for each subscale of the SF-36 and for PCS and MCS.
Measured: From Baseline Visit to Final Visit (up to 72 weeks)
MCID in CLDQ-HCV Scores
The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status perceived by themselves). The MCID was calculated for each domain of the CLDQ-HCV and for the CLDQ-HCV summary score.
Measured: From Baseline Visit to Final Visit (up to 72 weeks)
Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)
Compliance was calculated as the amount of dispensed medication minus the amount of medication returned by participants divided by amount of dispensed medication.
Measured: From Baseline Visit to Final Visit (up to 72 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009May 2013

First posted17 Mar 2009 (estimated)
Study startApr 2009
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00863109
Sponsor's protocol ID: P05278
Other IDs: MK-4031-336
Acronym: VIDA
Status last verified: Mar 2017
First submitted: 12 Mar 2009
Last updated: 7 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Health-Related Quality of Life During Combined Treatment of Chronic Hepatitis Due to Hepatitis C Virus Under Habitual Clinical Practise Conditions.
ClinicalTrials.gov ID: NCT00863109
Acronym / sponsor ID: VIDA / P05278
Conditions: Hepatitis C, Chronic, Genotype 1, HCV-1
Study type: Observational
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 17 Mar 2009 (estimated)
Results: Posted 12 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The sample size of the study must allow evaluating HRQL of HCV patients based on the SF-36 before PEG treatment and at each of the following study visits.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
PEG + RBV (Standard Clinical Practice)	–	Biological: Peginterferon alfa-2b (PEG), Drug: Ribavirin (RBV)Participants receive peginterferon alfa-2b (PEG) and ribavirin (RBV) in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with Chronic Hepatitis C, Genotype 1, no other co-infection and compensated liver disease who receive PEG and RBV in combination therapy according to standard clinical practice.

Key inclusion criteria (4 listed)

Participants diagnosed with chronic hepatitis C (CHC)
Participants with HCV genotype 1
Participants who, at the time of the study, are referred to the Hospital Pharmacy Service to begin treatment with PEG and RBV for 48 weeks
Available to understand and to give Informed Consent

Key exclusion criteria (1 listed)

Participants co-infected with Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peginterferon alfa-2b (PEG)Also: PegIntron, SCH 054031Pegylated interferon alfa-2b was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).	Biological	PEG + RBV (Standard Clinical Practice)
Ribavirin (RBV)Also: Rebetol, SCH 18908Ribavirin was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).	Drug	PEG + RBV (Standard Clinical Practice)

Primary outcome

Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores
Time frame: Baseline, Week 72
SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.
Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)
Time frame: Baseline, Week 72
The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life.

5 secondary outcomes

Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)
Time frame: Baseline, Week 72
Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)
Time frame: Baseline, Week 72
Minimal Clinically Important Difference (MCID) in SF-36 Scores
Time frame: From Baseline Visit to Final Visit (up to 72 weeks)
MCID in CLDQ-HCV Scores
Time frame: From Baseline Visit to Final Visit (up to 72 weeks)
Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)
Time frame: From Baseline Visit to Final Visit (up to 72 weeks)

Results and safety

Results posted to the registry on 12 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PEG + RBV (Standard Clinical Practice)	130	53

Primary outcome: Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores

Time frame: Baseline, Week 72. Mean (Standard Deviation). Unit: score on a scale

Measure	PEG + RBV (Standard Clinical Practice) n = 126
Physical Function-BL (n=123)	87.27 (20.67)
Physical Function-WK72 (n=45)	87.33 (16.08)
Physical Function Change from BL (n=45)	-1.56 (16.30)
Physical Role-BL (n=123)	81.71 (36.08)
Physical Role-WK72 (n=45)	86.67 (29.48)
Physical Role Change from BL (n=45)	-0.56 (35.15)
Pain-BL (n=126)	77.88 (23.96)
Pain-WK72 (n=46)	82.35 (21.41)

Population analysed: All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72.

Primary outcome: Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)

Time frame: Baseline, Week 72. Mean (Standard Deviation). Unit: score on a scale

Measure	PEG + RBV (Standard Clinical Practice) n = 125
Activity/Energy-BL (n=125)	5.58 (1.33)
Activity/Energy-WK72 (n=46)	5.76 (1.11)
Activity/Energy Change from BL (n=46)	-0.06 (1.16)
Emotional Function-BL (n=125)	5.19 (1.02)
Emotional Function-WK72 (n=46)	5.35 (0.97)
Emotional Function Change from BL (n=46)	0.10 (0.87)
Worry-BL (n=125)	5.26 (1.25)
Worry-WK72 (n=46)	5.65 (1.46)

PEG + RBV (Standard Clinical Practice): p = 0.027, Student´s t-test for paired samples

Population analysed: All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline visit to Final Visit (up to 72 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PEG + RBV (Standard Clinical Practice)	12 of 130 (9.2%)	116 of 130 (89.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic and Genotype 1, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores (time frame: Baseline, Week 72). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00863109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.