A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00800735
• Collaborator: (none)
• Enrollment: 30
• Locations: 23
• Arm: 1
• Duration (Months): 35
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus, 800-1200 mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48 weeks in genotype G1 with a treatment-free follow up period of 24 weeks.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic	Drug: Pegylated-interferon alfa-2a; Drug: Ribavirin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Multicenter Protocol Providing Pegylated-interferon Alfa-2a (PEGASYS®) as Monotherapy or in Combination With Ribavirin (COPEGUS®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Pegylated-interferon alfa-2a plus ribavirin Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.

Drug: Pegylated-interferon alfa-2a; Pegylated-interferon alfa-2a was administered subcutaneously once weekly.; Other Names: PEG-IFN alfa-2a Pegasys ; Drug: Ribavirin; Participants received ribavirin with food, as the bioavailability of ribavirin is increased when taken with food. Ribavirin was administered as split doses, that is, 2 doses were given 12 hours apart, 1 in the morning and 1 in the evening. Participants received either 1000 or 1200 mg ribavirin per day according to body weight: 400 mg (2 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing < 75 kg or 600 mg (3 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing ≥ 75 kg.; Other Names: Copegus Ro 20-9963

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Experienced at Least 1 Adverse Event. [Baseline through 24 weeks after the end of treatment (up to 72 weeks)]

   An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Adult patients, ≥ 18 years of age.

• Chronic hepatitis C (CHC) patients with compensated liver disease (Child-Pugh A) who have participated in a donor protocol where access to treatment or re-treatment with PEGASYS monotherapy or in combination with Copegus was promised or deemed appropriate after completion of the donor protocol.

Exclusion Criteria:

• Evidence of decompensated liver disease (Child B or C cirrhosis).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Sacramento	California	United States	95817
2		San Francisco	California	United States	94115
3		Lutherville	Maryland	United States	21093
4		Manhasset	New York	United States	11030
5		New York	New York	United States	10021
6		Chapel Hill	North Carolina	United States	27599-7584
7		Portland	Oregon	United States	97239
8		Providence	Rhode Island	United States	02905
9		Nashville	Tennessee	United States	37203
10		San Antonio	Texas	United States	78215
11		Salt Lake City	Utah	United States	84132
12		Wien		Austria	1090
13		Vancouver	British Columbia	Canada	V5Z 1H2
14		Vancouver	British Columbia	Canada	V5Z 1M9
15		Toronto	Ontario	Canada	M5G 1L7
16		Clichy		France	92118
17		Berlin		Germany	10969
18		Frankfurt Am Main		Germany	60590
19		Koeln		Germany	50924
20		Badalona		Spain	08915
21		Barcelona		Spain	08003
22		Madrid		Spain	28222
23		Valencia		Spain	46014

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00800735
• Other Study ID Numbers: NV21928; 2008-002022-10
• First Posted: Dec 2, 2008
• Last Update Posted: Oct 30, 2013
• Last Verified: Sep 1, 2013

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

Study Results

Participant Flow

Arm/Group Title	Pegylated-interferon Alfa-2a Plus Ribavirin
Arm/Group Description	Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
Period Title: Overall Study
STARTED	30
COMPLETED	16
NOT COMPLETED	14

Baseline Characteristics

Arm/Group Title	Pegylated-interferon Alfa-2a Plus Ribavirin
Arm/Group Description	Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.5 (9.35)
Sex: Female, Male (Count of Participants)
Female	18 60%
Male	12 40%
Race/Ethnicity, Customized (participants) [Number]
Black	2 6.7%
Caucasian	28 93.3%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	170.0 (7.28)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	76.97 (16.146)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.5 (4.53)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Experienced at Least 1 Adverse Event.
Description	An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame	Baseline through 24 weeks after the end of treatment (up to 72 weeks)

Outcome Measure Data

Analysis Population Description

All enrolled patients.

Arm/Group Title	Pegylated-interferon Alfa-2a Plus Ribavirin
Arm/Group Description	Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
Measure Participants	30
Number [Percentage of participants]	80.0 266.7%

Adverse Events

Time Frame	Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Adverse Event Reporting Description	Safety population: All enrolled participants.
Arm/Group Title	Pegylated-interferon Alfa-2a Plus Ribavirin
Arm/Group Description	Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
All Cause Mortality
	Pegylated-interferon Alfa-2a Plus Ribavirin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pegylated-interferon Alfa-2a Plus Ribavirin
	Affected / at Risk (%)	# Events
Total	4/30 (13.3%)
Eye disorders
Retinal haemorrhage	1/30 (3.3%)
Infections and infestations
Conjunctivitis viral	1/30 (3.3%)
Laryngitis	1/30 (3.3%)
Sinusitis	1/30 (3.3%)
Injury, poisoning and procedural complications
Arthropod bite	1/30 (3.3%)
Rib fracture	1/30 (3.3%)
Investigations
Prothrombin time prolonged	1/30 (3.3%)
Respiratory, thoracic and mediastinal disorders
Haemoptysis	1/30 (3.3%)
Other (Not Including Serious) Adverse Events
	Pegylated-interferon Alfa-2a Plus Ribavirin
	Affected / at Risk (%)	# Events
Total	23/30 (76.7%)
Blood and lymphatic system disorders
Anaemia	4/30 (13.3%)
Lymphopenia	4/30 (13.3%)
Endocrine disorders
Hyperthyroidism	2/30 (6.7%)
Gastrointestinal disorders
Dyspepsia	3/30 (10%)
Nausea	8/30 (26.7%)
Vomiting	3/30 (10%)
General disorders
Asthenia	5/30 (16.7%)
Chills	7/30 (23.3%)
Fatigue	16/30 (53.3%)
Influenza like illness	5/30 (16.7%)
Pyrexia	4/30 (13.3%)
Infections and infestations
Bronchitis	4/30 (13.3%)
Sinusitis	2/30 (6.7%)
Urinary tract infection	2/30 (6.7%)
Metabolism and nutrition disorders
Decreased appetite	3/30 (10%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/30 (13.3%)
Back pain	2/30 (6.7%)
Myalgia	4/30 (13.3%)
Nervous system disorders
Dizziness	2/30 (6.7%)
Headache	7/30 (23.3%)
Psychiatric disorders
Depression	5/30 (16.7%)
Insomnia	7/30 (23.3%)
Respiratory, thoracic and mediastinal disorders
Cough	4/30 (13.3%)
Dyspnoea	3/30 (10%)
Skin and subcutaneous tissue disorders
Alopecia	5/30 (16.7%)
Dry skin	5/30 (16.7%)
Pruritus	9/30 (30%)
Rash	6/30 (20%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.