Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009717

Trial Description

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Title

German Hepatitis C-Registry (DHC-R)

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Trial Acronym

DHC-R

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URL of the Trial

http://www.deutsches-hepatitis-c-register.de

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Brief Summary in Lay Language

For the optimzation of hepatitis c treatment with current and future treatment regimens more data are required as are available from pievotal studies. Thus, the German Hepatitis C-Registry (DHC-R) was founded. The registry aims to collect data on all available treatment regimens. Thus, more scientific findings will be generated. Those data will help to improve treatment of patients with hepatitis c.

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Brief Summary in Scientific Language

For the optimzation of hepatitis c treatment with current and future treatment regimens more data are required as are available from pievotal studies.
Thus, the German Hepatitis C-Registry (DHC-R) was founded. This prospective registry is one of the biggest registries aiming at collecting data on all available treatment regimens for a hepatitis c infection. This also includes regimens which are not yet approved. Thus, the registry can be extended immediately after approval of a new drug.
The registry can use data from approximately 40,000 patients already documented in the PAN registry (PAN - Peginterferon alfa-2a non-interventional study). The main object of the DHC-R is to add another 15,000 treated patients and 5,000 non-treated patients. The latter being followed up once a year.
With this broad database more scientific findings will be generated which will help to improve treatment of patients with hepatitis c.
As treatments with new direct antiviral agents are documented in private practices and hospitals within a real-world setting the efficiency of these new therapies can be analysed.

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Organizational Data

  •   DRKS00009717
  •   2015/11/30
  •   [---]*
  •   yes
  •   Approved
  •   2014-395-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   2493   (BfArM-NIS-Nr.)
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Health Condition or Problem studied

  •   B18.2 -  Chronic viral hepatitis C
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Interventions/Observational Groups

  •   Treatment of patients with cronic hepatitis c infection.

    Documentation of parameters from standard diagnostics, quality of life questionnaire (SF36) and (serious) adverse events.

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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Proportion of patients, who achieved sustained virological response 12 weeks after end of treatement (SVR12).

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Secondary Outcome

Safety & tolerability: all (severe) adverse events during treatment and follow-up period).
virological outcome: RVR, EVR, EoTR, SVR24, on-treatment failure, viral relapse rates.
Baseline including: Cirrhosis, previous therapy (if applicable), IL28B GT, BMI, Race, Age, viral genotype and viral load, rel-evant laboratory parameters, concomitant diseases.
Adherence to therapy.
Impact of successful therapy on morbidity and mortality on patients.
Patient reported outcomes (based on patient questionnaires and clinical outcomes).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   Actual
  •   2014/11/24
  •   20000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Chronic Hepatitis C Virus infection with viral replication (HCV-RNA +)

Patients which are treated with the following antiviral therapies can be documented in the registry:

Peg-Interferon alfa-2a± Ribavirin+Sofosbuvir;
Peg-Interferon alfa-2a±Ribavirin+Simeprevir;
Peg-Interferon alfa-2a±Ribavirin+Boceprevir;
Peg-Interferon alfa-2a±Ribavirin+Telaprevir;
Peg-Interferon alfa-2b±Ribavirin+Sofosbuvir;
Peg-Interferon alfa-2b±Ribavirin+Simeprevir;
Peg-Interferon alfa-2b±Ribavirin+Boceprevir;
Peg-Interferon alfa-2b ± Ribavirin+Telaprevir;
Paritaprevir/Ombitasvir+Dasabuvir±Ribavirin;
Paritaprevir/Ombitasvir±Ribavirin;
Paritaprevir/Ombitasvir±Dasabuvir±Sofosbuvir;
Simeprevir+Sofosbuvir±Ribavirin;
Simeprevir+Daclatasvir±Ribavirin;
Simeprevir+Sofosbuvir/Ledipasvir±Ribavirin;
Daclatasvir+Sofosbuvir±Ribavirin;
Elbasvir/Grazoprevir±Ribavirin;
Elbasvir/Grazoprevir+Sofosbuvir±Ribavirin;Sofosbuvir/Velpatasvir±Ribavirin; Glecaprevir/Pibrentasvir±Ribavirin; Sofosbuvir/Velpatasvir/Voxilaprevir±Ribavirin(exclusively as rescue therapy).

Moreover, patients which are not treated can also be documented in the registry. Patients are treated at the sole discretion of the physician.

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Exclusion Criteria

Pregnancy (patient or female partner of male patient), women in nursing period or women of childbearing age without reliable contraception. Contraindications for use of antiviral treatment. Treatment of hepatitis c, which is conducted in clinial trials of phase I to IV must not be documented in the DHC-R. Patients whose hepatitis c treatment is documented in other remunerated non-interventional studies are not allowed to be documented simultaneously in the DHC-R.

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Addresses

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    • Leberstiftungs-GmbH Deutschland
    • Mr.  Prof. Dr.  Heiner  Wedemeyer 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Berufsverband der Niedergelassenen Gastroenterologen Deutschlands e.V. (bng)
    • Holdergärten 13
    • 89081  Ulm
    • Germany
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    • Hepatologische Schwerpunktpraxis Herne
    • Mr.  Dr.  Dietrich  Hüppe 
    • Wiescherstraße 20
    • 44623  Herne
    • Germany
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    • Leberstiftungs-GmbH Deutschland
    • Ms.  Dr.  Yvonne  Serfert 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Leberstiftung
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Deutsches Zentrum für Infektionsforschung (DZIF)
    • Inhoffenstr. 7
    • 38124  Braunschweig
    • Germany
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    • AbbVie Deutschland GmbH & Co. KG
    • Mainzer Str. 81
    • 65189  Wiesbaden
    • Germany
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    • Bristol-Myers Squibb GmbH & Co.KGaA
    • Arnulfstr. 29
    • 80636  München
    • Germany
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    • Gilead Sciences GmbH
    • Fraunhoferstr. 17
    • 82152  Martinsried/München
    • Germany
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    • Janssen-Cilag GmbH
    • Johnson & Johnson Platz 1
    • 41470  Neuss
    • Germany
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    • MSD Sharp & Dohme GmbH
    • Lindenplatz 1
    • 85540  Haar
    • Germany
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    • Roche Pharma AG (finanzielle Unterstützung bis 14.07.17/financial support until 2017-07-14)
    • Emil-Barell-Str. 1
    • 79639  Grenzach-Wyhlen
    • Germany
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Status

  •   Recruiting ongoing
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* This entry means the parameter is not applicable or has not been set.