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临床试验/NCT01168856
NCT01168856终止不适用

A Long-term Monitoring Study to Evaluate the Persistence of Direct Antiviral (DAA) Treatment Resistant Mutations or the Durability of Sustained Virological Response (SVR) in Patients Treated With DAA Containing Regimens for Chronic Hepatitis C Infections (CHC)

Hoffmann-La Roche0 个研究点目标入组 734 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
734
主要终点
Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3

研究概览

简要总结

This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients, >/=18 years of age
  • chronic hepatitis C
  • participation in Roche DAA treatment protocol for CHC infection
  • DAA-associated resistant mutations persisting through to last evaluation in donor protocol , or partial viral response or viral load rebound while on RO5024048 treatment, or sustained virological response >/= 20 weeks after last dose of study medication in donor study

排除标准

  • For patients participating in DAA resistance monitoring: Initiation of treatment after participation in the donor protocol for which there is evidence of cross-resistance to donor protocol DAA
  • For patients participating in DAA SVR durability: Treatment with any anti-HVC therapy since establishing SVR in the donor study

结局指标

主要结局

Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3

时间窗: Month 3

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter \[IU/mL\]).

HCV RNA Levels in Resistance Monitoring Arm at Month 3

时间窗: Month 3

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

HCV RNA Levels in Resistance Monitoring Arm at Month 6

时间窗: Month 6

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6

时间窗: Month 6

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9

时间窗: Month 9

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

HCV RNA Levels in Resistance Monitoring Arm at Month 18

时间窗: Month 18

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12

时间窗: Month 12

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18

时间窗: Month 18

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

HCV RNA Levels in Resistance Monitoring Arm at Month 9

时间窗: Month 9

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

HCV RNA Levels in Resistance Monitoring Arm at Month 12

时间窗: Month 12

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3

时间窗: Month 3

Any abnormalities in systolic blood pressure (units: millimeters of Mercury \[Hg\] \[mmHg\]) were reported at the discretion of principal investigator.

Systolic Blood Pressure in Resistance Monitoring Arm at Month 9

时间窗: Month 9

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12

时间窗: Month 12

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18

时间窗: Month 18

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Systolic Blood Pressure in Resistance Monitoring Arm at Month 6

时间窗: Month 6

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6

时间窗: Month 6

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3

时间窗: Month 3

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6

时间窗: Month 6

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9

时间窗: Month 9

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12

时间窗: Month 12

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18

时间窗: Month 18

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Mean Pulse Rate in Resistance Monitoring Arm at Month 3

时间窗: Month 3

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Mean Pulse Rate in Resistance Monitoring Arm at Month 6

时间窗: Month 6

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Mean Pulse Rate in Resistance Monitoring Arm at Month 9

时间窗: Month 9

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Mean Pulse Rate in Resistance Monitoring Arm at Month 12

时间窗: Month 12

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Mean Pulse Rate in Resistance Monitoring Arm at Month 18

时间窗: Month 18

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm

时间窗: Up to 18 months

Percentage of participants who received any anti-HCV medication during the monitoring period was reported.

Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6

时间窗: Month 6

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12

时间窗: Month 12

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24

时间窗: Month 24

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36

时间窗: Month 36

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12

时间窗: Month 12

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24

时间窗: Month 24

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6

时间窗: Month 6

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Number of Participants With STV Resistance Status-Clonal Sequencing

时间窗: Month 3-18

Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance. Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688. Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688.

Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24

时间窗: Month 24

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24

时间窗: Month 24

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12

时间窗: Month 12

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36

时间窗: Month 36

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36

时间窗: Month 36

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6

时间窗: Month 6

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12

时间窗: Month 12

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36

时间窗: Month 36

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12

时间窗: Month 12

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688

时间窗: Month 18

Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.

Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6

时间窗: Month 6

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24

时间窗: Month 24

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36

时间窗: Month 36

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing

时间窗: Month 3-18

Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance. Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.

Number of Participants With DNV Resistance Status-Clonal Sequencing

时间窗: Month 3-18

Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study.

Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing

时间窗: Month 3-18

Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.

Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing

时间窗: Month 3-18

Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688.

Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing

时间窗: Month 3-18

Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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