Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
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ClinicalTrials.gov Identifier: NCT01063829 |
Recruitment Status :
Completed
First Posted : February 5, 2010
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HCMV Reactivation or HCMV End-Organ Disease | Drug: 60 mg AIC246 Drug: 120 mg AIC246 Drug: 240 mg AIC246 Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 133 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official 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 |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | December 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: Dose regimen 1
60 mg AIC246, one tablet per day
|
Drug: 60 mg AIC246
Oral administration |
Experimental: Dose regimen 2
120 mg AIC246, one tablet per day
|
Drug: 120 mg AIC246
Oral administration |
Experimental: Dose regimen 3
240 mg AIC246, one tablet per day
|
Drug: 240 mg AIC246
Oral administration |
Placebo
Placebo arm
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Other: Placebo
Oral administration |
- Number of Participants With "HCMV Prophylaxis Failure" [ Time Frame: 84 days ]
- Time to Onset of "HCMV Prophylaxis Failure" [ Time Frame: 84 days ]
- Number of Patients With Systemic Detectable HCMV Replication. [ Time Frame: 84 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063829

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AiCuris Anti-infective Cures GmbH |
ClinicalTrials.gov Identifier: | NCT01063829 |
Other Study ID Numbers: |
AIC246-01-II-02 |
First Posted: | February 5, 2010 Key Record Dates |
Results First Posted: | February 13, 2018 |
Last Update Posted: | February 13, 2018 |
Last Verified: | December 2010 |
HCMV |