Trial Outcomes & Findings for An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients (NCT NCT02118597)

NCT ID: NCT02118597

Last Updated: 2016-12-12

Results Overview

The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up.

• Recruitment status: TERMINATED
• Target enrollment: 19 participants
• Primary outcome timeframe: 24 weeks after end of treatment (EOT) at Week 72
• Results posted on: 2016-12-12

Participant Flow

A total of 19 participants were enrolled in 8 study centers.

Participant milestones

Measure	Triple Combination Therapy Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
Overall Study STARTED	19
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	Triple Combination Therapy Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
Overall Study Sponsor terminated the study	14
Overall Study Serious Adverse Event	1
Overall Study Investigator's decision	1

Baseline Characteristics

An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients

Baseline characteristics by cohort

Measure	Triple Combination Therapy n=19 Participants Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
Age, Continuous	52.73 years STANDARD_DEVIATION 10.85 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks after end of treatment (EOT) at Week 72

Population: Due to the early termination of the study follow-up of the vast majority of the participants was not possible and data were not collected. Therefore, results for this outcome measure are based on one participant.

The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up.

Outcome measures

Measure	Triple Combination Therapy n=1 Participants Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
Sustained Virological Response 24 (SVR24) Rate	0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 24

Population: Intent to treat (ITT) population included all enrolled participants. Here, 'n' indicated number of participants with virological response data at evaluated time points.

Virological response is defined as HCV RNA <15 IU/mL.

Outcome measures

Measure	Triple Combination Therapy n=19 Participants Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
Percentage of Participants With Virological Response Week 4 (n=3)	0.0 percentage of participants
Percentage of Participants With Virological Response Week 8 (n=18)	73.7 percentage of participants
Percentage of Participants With Virological Response Week 12 (n=17)	73.7 percentage of participants
Percentage of Participants With Virological Response Week 24 (n=16)	78.9 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: ITT population included all enrolled participants.

Virological breakthrough is defined as either HCV RNA >=15 IU/mL in participants with prior virological response or as an increase in HCV RNA >/=1 log10 above nadir.

Outcome measures

Measure	Triple Combination Therapy n=19 Participants Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
Number of Participants With Virological Breakthrough	1 participants

SECONDARY outcome

Timeframe: Week 49 up to Week 72

Population: ITT population included all enrolled participants.

Virological response is defined as HCV RNA >/=15 IU/mL during the treatment free follow-up period in participants with virological response at the end of treatment.

Outcome measures

Measure	Triple Combination Therapy n=19 Participants Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
Number of Participants With Virological Relapse	1 participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: ITT population included all enrolled participants.

Treatment discontinuation due to futility is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.

Outcome measures

Measure	Triple Combination Therapy n=19 Participants Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
Number of Participants With Treatment Discontinuation Due to Futility	2 participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: ITT population included all enrolled participants.

Treatment discontinuation is reported by sub-categories of reasons for treatment discontinuation. Futility rule is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.

Outcome measures

Measure	Triple Combination Therapy n=19 Participants Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
Number of Participants With Treatment Discontinuation Sponsor's decision	7 participants
Number of Participants With Treatment Discontinuation Adverse event	4 participants
Number of Participants With Treatment Discontinuation Futility rule	2 participants

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: ITT population included all enrolled participants.

An adverse event is any untoward medical occurrence in a participant 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.

Outcome measures

Measure	Triple Combination Therapy n=19 Participants Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
Number of Participants With Adverse Events	17 participants

SECONDARY outcome

Timeframe: Screening (before Week 1)

Population: Predictive values of participant demographics could not be analyzed as the SVR24 rate was based on one participant.

Demographic characteristics recorded were age and gender. Predictive value of these characteristics for SVR rate was to be assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening (before Week 1)

Population: Predictive values of sub-categories of liver fibrosis could not be analyzed as the SVR24 rate was based on one participant.

The following sub-categories of liver fibrosis were determined in this study: 1) no cirrhosis, 2) bridging fibrosis and 3) cirrhosis. Predictive value of these sub-categories of liver fibrosis for SVR rate was to be assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening (before Week 1)

Population: Predictive values of HCV disease characteristics could not be analyzed as the SVR24 rate was based on one participant.

HCV disease characteristics evaluated were HCV genotype (subtype), including HCV 1(a) and HCV 1(b). Predictive value of these disease characteristics for SVR rate were to be assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: Predictive values of previous virological response could not be analyzed as the SVR24 rate was based on one participant.

Previous virological response was sub-categorized into the following categories: null-response, partial response, or relapse. Predictive value of these sub-categories for SVR rate were to be assessed.

Outcome measures

Outcome data not reported

Adverse Events

Triple Combination Therapy

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Triple Combination Therapy n=19 participants at risk Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (Peg-interferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peg-interferon alfa-2a and ribavirin were observed.
Infections and infestations Administration site cellulitis	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Gastrointestinal disorders Ileus	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Blood and lymphatic system disorders Anaemia	15.8% 3/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Blood and lymphatic system disorders Neutropenia	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Blood and lymphatic system disorders Thrombocytopenia	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)

Other adverse events

Measure	Triple Combination Therapy n=19 participants at risk Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (Peg-interferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peg-interferon alfa-2a and ribavirin were observed.
General disorders Influenza like illness	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
General disorders Fatigue	15.8% 3/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
General disorders Oedema peripheral	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Skin and subcutaneous tissue disorders Rash	10.5% 2/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Skin and subcutaneous tissue disorders Dermatitis	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Skin and subcutaneous tissue disorders Hyperhidrosis	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Skin and subcutaneous tissue disorders Pruritus	10.5% 2/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Skin and subcutaneous tissue disorders Alopecia	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Endocrine disorders Hypothyroidism	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Gastrointestinal disorders Aphthous ulcer	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Gastrointestinal disorders Gastrooesophageal reflux disease	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Gastrointestinal disorders Vomiting	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Gastrointestinal disorders Nausea	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Gastrointestinal disorders Faeces soft	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Nervous system disorders Headache	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Nervous system disorders Dysgeusia	21.1% 4/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Respiratory, thoracic and mediastinal disorders Cough	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Respiratory, thoracic and mediastinal disorders Epistaxis	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Blood and lymphatic system disorders Anemia	42.1% 8/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Blood and lymphatic system disorders Neutropenia	5.3% 1/19 • From signing of informed consent form up to the end of study (up to 72 weeks)
Blood and lymphatic system disorders Thrombocytopenia	15.8% 3/19 • From signing of informed consent form up to the end of study (up to 72 weeks)

Additional Information

Medical Communications

Hoffmann-La Roche

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