Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003835

Trial Description

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Title

A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Safety, Tolerability and Antiviral Activity of 12 Weeks' Treatment With a New Antiviral HCMV Drug

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the
chances of the cytomegalovirus becoming active again and causing illness after an HBPC
transplant (allogeneic stem cell transplant).

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003835
  •   2012/11/30
  •   2010/02/04
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01063829  (ClinicalTrials.gov)
  •   AIC246-01-II-02  (AiCuris GmbH & Co.KG)
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Health Condition or Problem studied

  •   Cytomegalovirus
  •   B25 -  Cytomegaloviral disease
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Interventions/Observational Groups

  •   Drug: AIC246
  •   Drug: AIC246
  •   Drug: AIC246
  •   Other: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Other
  •   Prevention
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- HCMV reactivation or HCMV End-Organ Disease; time frame: 92 days

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Secondary Outcome

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Countries of Recruitment

  •   United States
  •   Germany
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2010/02/27
  •   132
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Seropositive for HCMV IgG antibodies before transplantation

- First allogeneic Human blood precursor cell (HBPC) transplantation performed for 1 of
the following diagnoses: leukaemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's
lymphoma, multiple myeloma, myelodysplastic and myeloproliferative disorder

- Evidence of post transplantation engraftment

- Able to swallow tablets.

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Exclusion Criteria

- Previous anti-HCMV therapy after this allogeneic HBPC transplantation

- Mismatched or cord blood transplant recipients

- Current or history of end-organ HCMV disease

- Graft versus host disease (GVHD)

- Impaired liver function

- Reduced renal function

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Addresses

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    • AiCuris GmbH & Co.KG
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/12/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2013/10/20
* This entry means the parameter is not applicable or has not been set.