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An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

12. Februar 2016 aktualisiert von: Hoffmann-La Roche

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)

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.

Studienübersicht

Status

Beendet

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

734

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Australien
    • New South Wales
      • Darlinghurst, New South Wales, Australien, 2010
      • Kingswood, New South Wales, Australien, 2747
      • Sydney, New South Wales, Australien, 2050
      • Westmead, New South Wales, Australien, 2145
    • Queensland
      • Greenslopes, Queensland, Australien, 4120
      • Herston, Queensland, Australien, 4029
      • Woolloongabba, Queensland, Australien, 4102
    • South Australia
      • Adelaide, South Australia, Australien, 5000
    • Victoria
      • Melbourne, Victoria, Australien, 3181
      • Melbourne, Victoria, Australien, 3186
  • Brasilien
    • BA
      • Salvador, BA, Brasilien, 40210-341
    • RS
      • Porto Alegre, RS, Brasilien, 90035-003
    • SP
      • Ribeirao Preto, SP, Brasilien, 14049-900
  • Deutschland
      • Berlin, Deutschland, 13353
      • Berlin, Deutschland, 10969
      • Frankfurt Am Main, Deutschland, 60590
      • Hamburg, Deutschland, 20099
      • Hannover, Deutschland, 30625
      • Muenchen, Deutschland, 81377
  • Frankreich
      • Clichy, Frankreich, 92118
      • Creteil, Frankreich, 94010
      • Lille, Frankreich, 59037
      • Marseille, Frankreich, 13285
      • Montpellier, Frankreich, 34295
      • Montpellier, Frankreich, 34094
      • Nice, Frankreich, 06202
      • Paris, Frankreich, 75651
      • Paris, Frankreich, 75679
      • Pessac, Frankreich, 33604
      • Rennes, Frankreich, 35033
      • Toulouse, Frankreich, 31059
      • Vandoeuvre-les-nancy, Frankreich, 54511
  • Italien
    • Campania
      • Napoli, Campania, Italien, 80131
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italien, 40138
    • Lombardia
      • Milano, Lombardia, Italien, 20162
      • Milano, Lombardia, Italien, 20121
      • Pavia, Lombardia, Italien, 27100
    • Piemonte
      • Torino, Piemonte, Italien, 10126
    • Puglia
      • Bari, Puglia, Italien, 70124
    • Toscana
      • Pisa, Toscana, Italien, 56124
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 4Z6
      • Edmonton, Alberta, Kanada, T6G 2B7
      • Edmonton, Alberta, Kanada, T6L5X8
    • British Columbia
      • Vancouver, British Columbia, Kanada, V5Z 1M9
      • Vancouver, British Columbia, Kanada, V5Z 1H2
      • Vancouver, British Columbia, Kanada, V6Z 2K5
      • Vancouver, British Columbia, Kanada, V6Z 2C7
      • Victoria, British Columbia, Kanada, V8V 3P9
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3E 3P4
    • Ontario
      • London, Ontario, Kanada, N6A 5A5
      • Ottawa, Ontario, Kanada, K1H 8L6
      • Toronto, Ontario, Kanada, M5T 2S8
      • Toronto, Ontario, Kanada, M5G 1L7
    • Quebec
      • Montreal, Quebec, Kanada, H3A 1A1
  • Mexiko
      • Guadalajara, Mexiko, 44650
      • Guadalajara, Mexiko, 44280
      • Monterrey, Mexiko, 64710
  • Neuseeland
      • Christchurch, Neuseeland, 8011
      • Dunedin, Neuseeland, 9016
      • Grafton, Neuseeland, 1010
  • Polen
      • Bydgoszcz, Polen, 85-030
      • Chorzow, Polen, 41-500
      • Lodz, Polen, 91-357
      • Myslowice, Polen, 41-400
      • Warszawa, Polen, 01-201
      • Warszawa, Polen, 02-507
      • Wrocław, Polen, 50-349
      • Łodz, Polen, 91-347
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
  • Slowakei
      • Bratislava, Slowakei, 831 01
  • Spanien
      • Barcelona, Spanien, 08003
      • Barcelona, Spanien, 08035
      • Madrid, Spanien, 28034
      • Madrid, Spanien, 28222
      • Madrid, Spanien, 28029
      • Pontevedra, Spanien, 36071
      • Sevilla, Spanien, 41014
      • Valencia, Spanien, 46014
    • Barcelona
      • Badalona, Barcelona, Spanien, 08915
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spanien, 07010
    • La Coruña
      • La Coruna, La Coruña, Spanien, 15006
    • Tenerife
      • La Laguna, Tenerife, Spanien, 38320
  • Vereinigte Staaten
    • California
      • La Jolla, California, Vereinigte Staaten, 92037-1030
      • Long Beach, California, Vereinigte Staaten, 90822
      • Sacramento, California, Vereinigte Staaten, 95817
      • Sacramento, California, Vereinigte Staaten, 95825
      • San Diego, California, Vereinigte Staaten, 92103-8465
      • San Francisco, California, Vereinigte Staaten, 94115
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80045
      • Englewood, Colorado, Vereinigte Staaten, 80113
    • Florida
      • Bradenton, Florida, Vereinigte Staaten, 34209
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30309
      • Decatur, Georgia, Vereinigte Staaten, 30033
      • Marietta, Georgia, Vereinigte Staaten, 30060
    • Hawaii
      • Honolulu, Hawaii, Vereinigte Staaten, 96814
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60637
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46202
    • Kansas
      • Kansas City, Kansas, Vereinigte Staaten, 66160-7222
    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten, 70112
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten, 48202
    • Missouri
      • Kansas City, Missouri, Vereinigte Staaten, 64131
    • New Hampshire
      • Lebanon, New Hampshire, Vereinigte Staaten, 03756
    • New Jersey
      • Hillsborough, New Jersey, Vereinigte Staaten, 08844
      • Newark, New Jersey, Vereinigte Staaten, 07102
    • New York
      • Manhasset, New York, Vereinigte Staaten, 11030
      • New York, New York, Vereinigte Staaten, 10021
      • New York, New York, Vereinigte Staaten, 10003
    • Rhode Island
      • Providence, Rhode Island, Vereinigte Staaten, 02905
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37211
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75246
      • Houston, Texas, Vereinigte Staaten, 77030
      • San Antonio, Texas, Vereinigte Staaten, 78212
      • San Antonio, Texas, Vereinigte Staaten, 78234
    • Virginia
      • Newport News, Virginia, Vereinigte Staaten, 23602
      • Richmond, Virginia, Vereinigte Staaten, 23249
    • Washington
      • Vancouver, Washington, Vereinigte Staaten, 98604
  • Vereinigtes Königreich
      • Dorset, Vereinigtes Königreich, BH7 7DW
      • Dundee, Vereinigtes Königreich, DD1 9SY
      • London, Vereinigtes Königreich, SE5 9RS
      • London, Vereinigtes Königreich, W2 1NY
      • London, Vereinigtes Königreich, E1 1BB
      • London, Vereinigtes Königreich, SW17 0QT
      • Manchester, Vereinigtes Königreich, M8 5RB
      • Nottingham, Vereinigtes Königreich, NG7 2UH
  • Österreich
      • Wien, Österreich, 1080

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

Chronic hepatitis C patients having received direct acting antiviral treatment in donor protocol

Beschreibung

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Kohorte

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3
Zeitfenster: Month 3
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter [IU/mL]).
Month 3
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6
Zeitfenster: Month 6
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 6
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9
Zeitfenster: Month 9
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 9
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12
Zeitfenster: Month 12
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 12
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18
Zeitfenster: Month 18
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 18
HCV RNA Levels in Resistance Monitoring Arm at Month 3
Zeitfenster: Month 3
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 3
HCV RNA Levels in Resistance Monitoring Arm at Month 6
Zeitfenster: Month 6
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 6
HCV RNA Levels in Resistance Monitoring Arm at Month 9
Zeitfenster: Month 9
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 9
HCV RNA Levels in Resistance Monitoring Arm at Month 12
Zeitfenster: Month 12
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 12
HCV RNA Levels in Resistance Monitoring Arm at Month 18
Zeitfenster: Month 18
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 18
Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3
Zeitfenster: Month 3
Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator.
Month 3
Systolic Blood Pressure in Resistance Monitoring Arm at Month 6
Zeitfenster: Month 6
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Month 6
Systolic Blood Pressure in Resistance Monitoring Arm at Month 9
Zeitfenster: Month 9
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Month 9
Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12
Zeitfenster: Month 12
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Month 12
Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18
Zeitfenster: Month 18
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Month 18
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3
Zeitfenster: Month 3
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Month 3
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6
Zeitfenster: Month 6
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Month 6
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9
Zeitfenster: Month 9
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Month 9
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12
Zeitfenster: Month 12
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Month 12
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18
Zeitfenster: Month 18
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Month 18
Mean Pulse Rate in Resistance Monitoring Arm at Month 3
Zeitfenster: Month 3
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Month 3
Mean Pulse Rate in Resistance Monitoring Arm at Month 6
Zeitfenster: Month 6
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Month 6
Mean Pulse Rate in Resistance Monitoring Arm at Month 9
Zeitfenster: Month 9
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Month 9
Mean Pulse Rate in Resistance Monitoring Arm at Month 12
Zeitfenster: Month 12
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Month 12
Mean Pulse Rate in Resistance Monitoring Arm at Month 18
Zeitfenster: Month 18
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Month 18
Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm
Zeitfenster: Up to 18 months
Percentage of participants who received any anti-HCV medication during the monitoring period was reported.
Up to 18 months
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6
Zeitfenster: Month 6
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 6
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12
Zeitfenster: Month 12
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 12
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24
Zeitfenster: Month 24
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 24
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36
Zeitfenster: Month 36
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 36
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6
Zeitfenster: Month 6
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 6
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12
Zeitfenster: Month 12
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 12
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24
Zeitfenster: Month 24
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 24
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36
Zeitfenster: Month 36
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Month 36
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6
Zeitfenster: Month 6
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Month 6
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12
Zeitfenster: Month 12
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Month 12
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24
Zeitfenster: Month 24
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Month 24
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36
Zeitfenster: Month 36
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Month 36
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6
Zeitfenster: Month 6
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Month 6
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12
Zeitfenster: Month 12
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Month 12
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24
Zeitfenster: Month 24
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Month 24
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36
Zeitfenster: Month 36
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Month 36
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6
Zeitfenster: Month 6
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Month 6
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12
Zeitfenster: Month 12
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Month 12
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24
Zeitfenster: Month 24
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Month 24
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36
Zeitfenster: Month 36
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Month 36
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing
Zeitfenster: 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.
Month 3-18
Number of Participants With DNV Resistance Status-Clonal Sequencing
Zeitfenster: 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.
Month 3-18
Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing
Zeitfenster: 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.
Month 3-18
Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing
Zeitfenster: 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.
Month 3-18
Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing
Zeitfenster: 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.
Month 3-18
Number of Participants With STV Resistance Status-Clonal Sequencing
Zeitfenster: 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.
Month 3-18
Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688
Zeitfenster: Month 18
Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.
Month 18

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2010

Primärer Abschluss (Tatsächlich)

1. April 2015

Studienabschluss (Tatsächlich)

1. April 2015

Studienanmeldedaten

Zuerst eingereicht

15. Juli 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juli 2010

Zuerst gepostet (Schätzen)

23. Juli 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

11. März 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Februar 2016

Zuletzt verifiziert

1. Februar 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NV22688
  • 2009-016560-36 (EudraCT-Nummer)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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