Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)

PEG-Intron(TM) Maintenance Therapy vs. an Untreated Control Group for Prevention of Progression of Fibrosis in Adult Subjects With Chronic Hepatitis C With Hepatic Fibrosis (METAVIR Fibrosis Score of F2 or F3), Who Failed Therapy With PEG-Intron Plus REBETOL(R) (in Protocol No. P02370)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00049842

Enrollment

540

Registered

2002-11-15

Start date

2002-10-31

Completion date

2009-10-31

Last updated

2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C, Liver Fibrosis

Brief summary

The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol treatment in protocol P02370 (NCT00039871).

Interventions

BIOLOGICALpeginterferon alfa-2b (SCH 54031)

0.5 µg/kg Weekly QW SC for 36 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age at entry in study P02370 (NCT00039871) 18-65 years; * Nonresponder to PEG-Intron plus Rebetol in study P02370

Exclusion criteria

* Participants who did not participate in the P02370 study. * Any medical condition, including but not limited to decompensated liver disease, malignancy or substance abuse, that developed during the P02370 study which could interfere with the participant's participation in and completion of this study.

Design outcomes

Primary

Measure	Time frame	Description
Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3).	Baseline to up to Month-36	Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis). Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.

Secondary

Measure	Time frame	Description
Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline)	Baseline to up to Month-36	Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis). Changes in liver inflammation defined as follows: Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.
Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale)	Baseline to up to Month-36	The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline. Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis).
The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline	Baseline to up to Month-36	Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis). Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.
Mean Change in the METAVIR Activity Score (Using a Continuous Scale)	Baseline to up to Month-36	The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline. Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis).
Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment.	Baseline to up to Month-36	Definitions: Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis). Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.

Participant flow

Participants by arm

Arm	Count
PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW) PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up	270
Untreated Control Participants were observed (no treatment given) for 36 months with 4-week follow-up	270
Total	540

Withdrawals & dropouts

Period	Reason	FG000	FG001
Follow-up Phase	Adverse Event	6	1
Follow-up Phase	Other	1	4
Treatment Phase	Administrative	0	3
Treatment Phase	Adverse Event	47	12
Treatment Phase	Did not meet protocol eligibility	0	1
Treatment Phase	Lost to Follow-up	4	8
Treatment Phase	Non-compliance with protocol	7	8
Treatment Phase	Withdrawal by Subject	35	46

Baseline characteristics

Characteristic	PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)	Untreated Control	Total
Age, Customized <=50 years	145 participants	148 participants	293 participants
Age, Customized >50 years	125 participants	122 participants	247 participants
Sex: Female, Male Female	76 Participants	81 Participants	157 Participants
Sex: Female, Male Male	194 Participants	189 Participants	383 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	234 / 270	200 / 270
serious Total, serious adverse events	53 / 270	31 / 270

Outcome results

Primary

Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3).

Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis). Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.