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Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01063829
Enrollment
133
Registered
2010-02-05
Start date
2010-03-31
Completion date
2011-12-31
Last updated
2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCMV Reactivation or HCMV End-Organ Disease

Keywords

HCMV

Brief summary

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).

Interventions

DRUG60 mg AIC246

Oral administration

DRUG120 mg AIC246

Oral administration

DRUG240 mg AIC246

Oral administration

OTHERPlacebo

Oral administration

Sponsors

Quintiles, Inc.
CollaboratorINDUSTRY
AiCuris Anti-infective Cures AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Number of Participants With HCMV Prophylaxis Failure84 days
Time to Onset of HCMV Prophylaxis Failure84 days

Secondary

MeasureTime frame
Number of Patients With Systemic Detectable HCMV Replication.84 days

Countries

Germany, United States

Participant flow

Pre-assignment details

133 patients were randomized to the trial; 2 randomized patients did not receive the assigned study drug ( 1 Patient died and 1 Patient had CMV reactivation before intended administartion of first dose)

Participants by arm

ArmCount
AIC246 (60 mg)
AIC246: Oral Administration
33
AIC246 (120 mg)
AIC246: Oral Administration
31
AIC246 (240 mg)
AIC246: Oral Administration
34
Placebo
Placebo: Oral Administration
33
Total131

Baseline characteristics

CharacteristicPlaceboTotalAIC246 (60 mg)AIC246 (120 mg)AIC246 (240 mg)
Age, Continuous51.8 years
STANDARD_DEVIATION 13.41
51.1 years
STANDARD_DEVIATION 12.62
50.5 years
STANDARD_DEVIATION 13.03
51.6 years
STANDARD_DEVIATION 12.79
50.7 years
STANDARD_DEVIATION 11.78
Region of Enrollment
Germany
18 participants62 participants15 participants12 participants17 participants
Region of Enrollment
United States
15 participants69 participants18 participants19 participants17 participants
Sex: Female, Male
Female
14 Participants54 Participants19 Participants9 Participants12 Participants
Sex: Female, Male
Male
19 Participants77 Participants14 Participants22 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
2 / 331 / 311 / 341 / 33
other
Total, other adverse events
31 / 3329 / 3134 / 3433 / 33
serious
Total, serious adverse events
13 / 3315 / 3112 / 3416 / 33

Outcome results

Primary

Number of Participants With HCMV Prophylaxis Failure

Time frame: 84 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AIC246 (60 mg)Number of Participants With HCMV Prophylaxis Failure16 Participants
AIC246 (120 mg)Number of Participants With HCMV Prophylaxis Failure10 Participants
AIC246 (240 mg)Number of Participants With HCMV Prophylaxis Failure10 Participants
PlaceboNumber of Participants With HCMV Prophylaxis Failure21 Participants
p-value: 0.007Fisher Exact
p-value: 0.014Fisher Exact
p-value: 0.321Fisher Exact
Primary

Time to Onset of HCMV Prophylaxis Failure

Time frame: 84 days

ArmMeasureValue (NUMBER)
AIC246 (60 mg)Time to Onset of HCMV Prophylaxis Failure7 days
AIC246 (120 mg)Time to Onset of HCMV Prophylaxis Failure6 days
AIC246 (240 mg)Time to Onset of HCMV Prophylaxis Failure2 days
PlaceboTime to Onset of HCMV Prophylaxis Failure12 days
p-value: 0.002Log Rank
p-value: 0.126Log Rank
p-value: 0.148Log Rank
Secondary

Number of Patients With Systemic Detectable HCMV Replication.

Time frame: 84 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AIC246 (60 mg)Number of Patients With Systemic Detectable HCMV Replication.7 Participants
AIC246 (120 mg)Number of Patients With Systemic Detectable HCMV Replication.5 Participants
AIC246 (240 mg)Number of Patients With Systemic Detectable HCMV Replication.2 Participants
PlaceboNumber of Patients With Systemic Detectable HCMV Replication.12 Participants
p-value: 0.007Fisher Exact
p-value: 0.014Fisher Exact
p-value: 0.321Fisher Exact

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026