Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00724451
• Collaborator: (none)
• Enrollment: 1,128
• Duration (Months): 39

Study Details

Study Description

Brief Summary

The goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment. The study is conducted in common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for antiviral therapy will be treated at the discretion of the physician with either peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in accordance with approved labeling. A secondary objective of this study is to define "treatment failure" and to evaluate the reasons for treatment discontinuation.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C; Hepatitis C, Chronic	Biological: Peginterferon alfa-2b; Drug: Ribavirin; Biological: Peginterferon alfa-2a

Detailed Description

Probability sampling: Consecutive adult patients with chronic hepatitis C in clinical practice at approximately 54 sites in Italy will be included in the study. The decision as to treatment choice falls at the discretion of the treating physician.

Study Design

• Study Type: Observational
• Actual Enrollment: 1128 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Prospective, Observational, Multicentre Study Evaluating HCV Patients Characteristics of Eligibility and Disease Management in Real Clinical Practice
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Participants with Chronic Hepatitis C (CHC) Peginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin.

Biological: Peginterferon alfa-2b; Peginterferon alfa-2b administered in accordance with approved labeling; Other Names: SCH 054031 PegIntron ; Drug: Ribavirin; Ribavirin administered in accordance with approved labeling; Other Names: SCH 018908 Copegus Rebetol Virazole RBV ; Biological: Peginterferon alfa-2a; Peginterferon alfa-2a administered in accordance with approved labeling; Other Names: Pegasys

Outcome Measures

Primary Outcome Measures

1. Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility [Measured at baseline]

   Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.

Secondary Outcome Measures

1. Number of Participants Discontinued From Treatment by Reason for Discontinuation [24 weeks after the end of treatment (total of 48 to 72 weeks)]

   Investigators recorded reasons for treatment discontinuation.

2. Number of Participants With Treatment Failure by Reason for Failure [24 to 48 weeks]

   Investigators recorded reasons for treatment failure whether or not treatment was completed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Willingness to sign an Informed Consent

• Male and female patients >=18 years of age with Chronic Hepatitis C

• Not previously treated with Peg-Interferons

• Positive for serum hepatitis C virus (HCV)-ribonucleic acid (RNA)

Exclusion Criteria:

• Previous treatment with peginterferon

• Participation in a therapeutic Good Clinical Practice (GCP) clinical study within 30 days prior to study start

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00724451
• Other Study ID Numbers: P05488
• First Posted: Jul 29, 2008
• Last Update Posted: Sep 25, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Ribavirin; Peginterferon alfa-2a; Peginterferon alfa-2b

Study Results

Participant Flow

Arm/Group Title	Participants With Chronic Hepatitis C (CHC)
Arm/Group Description	Peginterferon-naïve participants with chronic hepatitis C (CHC) seen in general clinical practice in Italy.
Period Title: Overall Study
STARTED	1128
Received Antiviral Treatment	500
COMPLETED	326
NOT COMPLETED	802

Baseline Characteristics

Arm/Group Title	Participants With Chronic Hepatitis C (CHC)
Arm/Group Description	Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
Overall Participants	1118
Age, Customized (participants) [Number]
18-29 years	51 4.6%
30-39 years	119 10.6%
40-49 years	244 21.8%
50-59 years	211 18.9%
60-69 years	263 23.5%
70-79 years	210 18.8%
≥80 years	20 1.8%
Sex: Female, Male (Count of Participants)
Female	541 48.4%
Male	577 51.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
Description	Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.
Time Frame	Measured at baseline

Outcome Measure Data

Analysis Population Description

431 of the 1118 participants were determined to be non-eligible for antiviral therapy by Investigator decision.

Arm/Group Title	Participants With Chronic Hepatitis C (CHC)
Arm/Group Description	Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
Measure Participants	431
Age	144 12.9%
Mild disease	77 6.9%
Substance abuse history	17 1.5%
Treatment postponed	7 0.6%
Genotype	2 0.2%
Comorbidity	139 12.4%
Liver problems	41 3.7%
Problems with previous treatment	4 0.4%

2. Secondary Outcome

Title	Number of Participants Discontinued From Treatment by Reason for Discontinuation
Description	Investigators recorded reasons for treatment discontinuation.
Time Frame	24 weeks after the end of treatment (total of 48 to 72 weeks)

Outcome Measure Data

Analysis Population Description

Reasons for treatment discontinuations were recorded by Investigators for 174 of the 500 treated participants.

Arm/Group Title	Participants With Chronic Hepatitis C (CHC)
Arm/Group Description	Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
Measure Participants	174
Disease worsening	3 0.3%
Side effects	27 2.4%
Non response	44 3.9%
Adverse effect	32 2.9%
Administrative reason	5 0.4%
Virological response	22 2%
Other reasons	5 0.4%

3. Secondary Outcome

Title	Number of Participants With Treatment Failure by Reason for Failure
Description	Investigators recorded reasons for treatment failure whether or not treatment was completed.
Time Frame	24 to 48 weeks

Outcome Measure Data

Analysis Population Description

132 of the 500 treated participants failed treatment per Investigator assessment.

Arm/Group Title	Participants With Chronic Hepatitis C (CHC)
Arm/Group Description	Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
Measure Participants	132
Disease relapse	71 6.4%
Non-responder	61 5.5%

Adverse Events

Adverse Event Reporting Description	500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
Arm/Group Title	Participants With Chronic Hepatitis C (CHC)
Arm/Group Description	Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
All Cause Mortality
	Participants With Chronic Hepatitis C (CHC)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Participants With Chronic Hepatitis C (CHC)
	Affected / at Risk (%)	# Events
Total	6/500 (1.2%)
Blood and lymphatic system disorders
Anaemia	1/500 (0.2%)	1
Neutropenia	1/500 (0.2%)	1
Thrombocytopenia	1/500 (0.2%)	1
General disorders
Asthenia	1/500 (0.2%)	1
Infections and infestations
Bronchopneumonia	1/500 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant	1/500 (0.2%)	1
Non-hodgkin's lymphoma	1/500 (0.2%)	1
Nervous system disorders
Cerebrovascular accident	1/500 (0.2%)	1
Hemiplegia	1/500 (0.2%)	1
Polyneuropathy	1/500 (0.2%)	1
Reproductive system and breast disorders
Prostatitis	1/500 (0.2%)	1
Vascular disorders
Haemorrhage	1/500 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Participants With Chronic Hepatitis C (CHC)
	Affected / at Risk (%)	# Events
Total	169/500 (33.8%)
Blood and lymphatic system disorders
Anaemia	64/500 (12.8%)	65
Haemoglobinaemia	1/500 (0.2%)	1
Leukopenia	10/500 (2%)	10
Neutropenia	23/500 (4.6%)	23
Thrombocytopenia	5/500 (1%)	5
Cardiac disorders
Tachycardia	3/500 (0.6%)	3
Ear and labyrinth disorders
Deafness	1/500 (0.2%)	1
Vertigo	2/500 (0.4%)	2
Endocrine disorders
Autoimmune thyroiditis	2/500 (0.4%)	2
Hyperthyroidism	4/500 (0.8%)	4
Hypothyroidism	7/500 (1.4%)	7
Eye disorders
Chalazion	1/500 (0.2%)	1
Eye pain	1/500 (0.2%)	1
Visual acuity reduced	1/500 (0.2%)	1
Gastrointestinal disorders
Abdominal pain	2/500 (0.4%)	2
Abdominal pain upper	6/500 (1.2%)	7
Aerophagia	1/500 (0.2%)	1
Aphthous stomatitis	1/500 (0.2%)	1
Ascites	3/500 (0.6%)	3
Constipation	1/500 (0.2%)	1
Diarrhoea	4/500 (0.8%)	4
Dry mouth	1/500 (0.2%)	1
Dyspepsia	1/500 (0.2%)	1
Gastritis	3/500 (0.6%)	3
Gastrointestinal disorder	1/500 (0.2%)	1
Gastrooesophageal reflux disease	1/500 (0.2%)	1
Gingivitis	1/500 (0.2%)	1
Haemorrhoids	3/500 (0.6%)	3
Ileus	1/500 (0.2%)	1
Inguinal hernia	1/500 (0.2%)	1
Nausea	8/500 (1.6%)	8
Rectal haemorrhage	1/500 (0.2%)	1
General disorders
Asthenia	47/500 (9.4%)	47
Chest pain	2/500 (0.4%)	2
Chills	1/500 (0.2%)	1
Fatigue	3/500 (0.6%)	3
Hyperpyrexia	7/500 (1.4%)	7
Influenza like illness	19/500 (3.8%)	19
Injection site reaction	2/500 (0.4%)	2
Irritability	3/500 (0.6%)	3
Malaise	1/500 (0.2%)	1
Pain	1/500 (0.2%)	1
Pyrexia	19/500 (3.8%)	19
Hepatobiliary disorders
Gallbladder disorder	1/500 (0.2%)	1
Infections and infestations
Cystitis	1/500 (0.2%)	1
Herpes simplex	1/500 (0.2%)	1
Pneumonia	3/500 (0.6%)	3
Tooth abscess	1/500 (0.2%)	1
Investigations
Blood thyroid stimulating hormone increased	1/500 (0.2%)	1
Platelet count decreased	1/500 (0.2%)	1
Serum ferritin increased	1/500 (0.2%)	1
Thyroid function test abnormal	1/500 (0.2%)	1
Weight decreased	12/500 (2.4%)	12
Metabolism and nutrition disorders
Decreased appetite	6/500 (1.2%)	6
Insulin resistance	1/500 (0.2%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	2/500 (0.4%)	2
Back pain	3/500 (0.6%)	3
Bone pain	3/500 (0.6%)	3
Musculoskeletal pain	4/500 (0.8%)	4
Myalgia	1/500 (0.2%)	1
Pain in extremity	1/500 (0.2%)	1
Nervous system disorders
Dementia	1/500 (0.2%)	1
Disturbance in attention	1/500 (0.2%)	1
Dizziness	3/500 (0.6%)	3
Dysgeusia	1/500 (0.2%)	1
Headache	12/500 (2.4%)	12
Paraesthesia	2/500 (0.4%)	2
Polyneuropathy	1/500 (0.2%)	1
Syncope	2/500 (0.4%)	2
Psychiatric disorders
Agitation	1/500 (0.2%)	1
Anxiety	11/500 (2.2%)	11
Apathy	1/500 (0.2%)	1
Depression	8/500 (1.6%)	8
Generalised anxiety disorder	1/500 (0.2%)	1
Insomnia	11/500 (2.2%)	11
Mood altered	1/500 (0.2%)	1
Nervousness	3/500 (0.6%)	3
Panic attack	1/500 (0.2%)	1
Renal and urinary disorders
Dysuria	1/500 (0.2%)	1
Reproductive system and breast disorders
Erectile dysfunction	1/500 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Cough	8/500 (1.6%)	8
Dyspoenia	2/500 (0.4%)	2
Haemoptysis	1/500 (0.2%)	1
Oropharyngeal pain	1/500 (0.2%)	1
Skin and subcutaneous tissue disorders
Alopecia	6/500 (1.2%)	6
Dermatitis	3/500 (0.6%)	3
Dry skin	1/500 (0.2%)	1
Erythema	2/500 (0.4%)	2
Pruritis	14/500 (2.8%)	14
Psoriasis	3/500 (0.6%)	3
Rash	7/500 (1.4%)	7
Trichorrhexis	1/500 (0.2%)	1
Urticaria	1/500 (0.2%)	1
Vitiligo	1/500 (0.2%)	1
Vascular disorders
Hypertension	2/500 (0.4%)	2
Hypotension	1/500 (0.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The principal investigator agrees not to publish or publicly present any interim results of the Study without prior written consent of the sponsor. The principal investigator further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of abstracts or manuscripts for publication.