Trial Outcomes & Findings for A Retrospective Study of Real World Treatment Outcomes of Patients With Chronic Hepatitis C (NCT NCT01705717)

NCT ID: NCT01705717

Last Updated: 2017-04-10

Results Overview

SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.

• Recruitment status: COMPLETED
• Target enrollment: 49 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-04-10

Participant Flow

Participant milestones

Measure	Non-Cirrhotic Chronic Hepatitis C (CHC) Observation Only Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.	Hepatitis C Virus (HCV) - Related Cirrhosis Observation Only Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
Overall Study STARTED	37	12
Overall Study COMPLETED	35	7
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Non-Cirrhotic Chronic Hepatitis C (CHC) Observation Only Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.	Hepatitis C Virus (HCV) - Related Cirrhosis Observation Only Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
Overall Study Adverse Event	2	2
Overall Study Lack of Efficacy	0	1
Overall Study Other	0	2

Baseline Characteristics

A Retrospective Study of Real World Treatment Outcomes of Patients With Chronic Hepatitis C

Baseline characteristics by cohort

Measure	Non-Cirrhotic CHC Observation Only n=37 Participants Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.	HCV - Related Cirrhosis Observation Only n=12 Participants Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.	Total n=49 Participants Total of all reporting groups
Age, Continuous	44.8 years STANDARD_DEVIATION 10.9 • n=5 Participants	53.9 years STANDARD_DEVIATION 8.2 • n=7 Participants	47.2 years STANDARD_DEVIATION 10.77 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	8 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All enrolled participants.

SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.

Outcome measures

Measure	Non-Cirrhotic CHC Observation Only n=37 Participants Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.	HCV - Related Cirrhosis Observation Only n=12 Participants Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy	59.5 percentage of participants	58.3 percentage of participants

SECONDARY outcome

Timeframe: End of Study, up to 36 months after diagnosis.

Population: All enrolled participants

End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.

Outcome measures

Measure	Non-Cirrhotic CHC Observation Only n=37 Participants Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.	HCV - Related Cirrhosis Observation Only n=12 Participants Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
Percentage of Participants Who Were HCV Seronegative at the End of Treatment	91.9 percentage of participants	91.6 percentage of participants

SECONDARY outcome

Timeframe: End of Study, up to 36 months after diagnosis.

Population: All enrolled participants;

HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT.

Outcome measures

Measure	Non-Cirrhotic CHC Observation Only n=22 Participants Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.	HCV - Related Cirrhosis Observation Only n=7 Participants Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion Virological Relapse	0 percentage of participants	0 percentage of participants
Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion Biochemical Relapse	0 percentage of participants	14.3 percentage of participants

SECONDARY outcome

Timeframe: Diagnosis and End of Study, up to 36 months after diagnosis.

Population: All enrolled participants

Outcome measures

Measure	Non-Cirrhotic CHC Observation Only n=37 Participants Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.	HCV - Related Cirrhosis Observation Only n=12 Participants Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
Percentage of Participants Who Progressed From CHC to Cirrhosis	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Diagnosis and End of Study, up to 36 months after diagnosis.

Population: All enrolled participants

Outcome measures

Measure	Non-Cirrhotic CHC Observation Only n=37 Participants Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.	HCV - Related Cirrhosis Observation Only n=12 Participants Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)	2.7 percentage of participants	8.3 percentage of participants

SECONDARY outcome

Timeframe: Diagnosis and End of Study, up to 36 months after diagnosis

Population: All enrolled participants

Any cause of death (including non-liver disease related) was reported.

Outcome measures

Measure	Non-Cirrhotic CHC Observation Only n=37 Participants Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.	HCV - Related Cirrhosis Observation Only n=12 Participants Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
Percentage of Participants Who Died	2.7 percentage of participants	0 percentage of participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=47 participants at risk Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC or HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
Blood and lymphatic system disorders Anemia	2.1% 1/47 • Adverse events (AEs) were recorded from the begininng of treatment through the end of the study, approximately 36 months. This was a retrospective analysis study; safety reporting was generated spontaneously by physician discretion. All participants for whom safety data was collected are included in the safety analysis. Systematic collection of safety data was not mandatory according to the protocol.
Blood and lymphatic system disorders Leucopenia	2.1% 1/47 • Adverse events (AEs) were recorded from the begininng of treatment through the end of the study, approximately 36 months. This was a retrospective analysis study; safety reporting was generated spontaneously by physician discretion. All participants for whom safety data was collected are included in the safety analysis. Systematic collection of safety data was not mandatory according to the protocol.
Vascular disorders Intracranial hemorrhage	2.1% 1/47 • Adverse events (AEs) were recorded from the begininng of treatment through the end of the study, approximately 36 months. This was a retrospective analysis study; safety reporting was generated spontaneously by physician discretion. All participants for whom safety data was collected are included in the safety analysis. Systematic collection of safety data was not mandatory according to the protocol.
Renal and urinary disorders Renal impairment	2.1% 1/47 • Adverse events (AEs) were recorded from the begininng of treatment through the end of the study, approximately 36 months. This was a retrospective analysis study; safety reporting was generated spontaneously by physician discretion. All participants for whom safety data was collected are included in the safety analysis. Systematic collection of safety data was not mandatory according to the protocol.
Blood and lymphatic system disorders Severe anemia	2.1% 1/47 • Adverse events (AEs) were recorded from the begininng of treatment through the end of the study, approximately 36 months. This was a retrospective analysis study; safety reporting was generated spontaneously by physician discretion. All participants for whom safety data was collected are included in the safety analysis. Systematic collection of safety data was not mandatory according to the protocol.

Additional Information

Medical Communications

Hoffman-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER