HCMV Reactivation or HCMV End-Organ DiseasePhase 2NCT01063829

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

A Phase 2 study testing 60 mg AIC246, 120 mg AIC246 and 240 mg AIC246 in people with HCMV Reactivation or HCMV End-Organ Disease, run by AiCuris Anti-infective Cures AG at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HCMV Reactivation or HCMV End-Organ Disease
What is being tested?: 60 mg AIC246, 120 mg AIC246 and 240 mg AIC246
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 133 participants
Where: 24 sitesin 2 countries
Study dates: Mar 2010to Dec 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

24 sites in 2 countries.

Country

City, postcode or hospital

24 sites in 2 countries

United States14 sites

Indiana BMT
Beech Grove, Indiana
Dana Farber Cancer Institute,
Boston, Massachusetts
University of Chicago Medical Center
Chicago, Illinois
Denver St. Lukes Presbyterian
Denver, Colorado
Karmanos Cancer Institute
Detroit, Michigan
University of Florida
Gainesville, Florida
MD Anderson Cancer Center
Houston, Texas
University Of Iowa
Iowa City, Iowa
UCLA Medical Center
Los Angeles, California
Loyola University Chicago
Maywood, Illinois
University of Minnesota
Minneapolis, Minnesota
Jeanes Hospital of TUHS
Philadelphia, Pennsylvania
UPMC Cancer Center
Pittsburgh, Pennsylvania
Stanford University Hospital
Stanford, California

Other trials in United States

Germany10 sites

Universitaetsklinikum Dresden
Dresden
Universitaetsklinikum Erlangen-PS
Erlangen
Universitätsklinikum Freiburg
Freiburg im Breisgau
Universitaetsklinikum Hamburg-Eppendorf
Hamburg
Universitaeetsklinikum Heidelberg, ,
Heidelberg
Universitaetsklinikum Mainz
Mainz
Universitaetsklinikum Muenster
Münster
Klinikum Nuernberg Nord
Nuremberg
Robert-Bosch-Krankenhaus
Stuttgart
Universitaetsklinikum Wuerzburg
Würzburg

Other trials in Germany

About this study

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

Conditions: HCMV Reactivation or HCMV End-Organ Disease
Being tested: 60 mg AIC246, 120 mg AIC246, 240 mg AIC246, Placebo
Keywords: HCMV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

60 mg AIC246Drug
Oral administration
120 mg AIC246Drug
Oral administration
240 mg AIC246Drug
Oral administration
PlaceboOther
Oral administration

Study groups in NCT01063829
Study group	Role	What they receive
Dose regimen 1	Experimental	60 mg AIC246, one tablet per day Receives: Drug: 60 mg AIC246
Dose regimen 2	Experimental	120 mg AIC246, one tablet per day Receives: Drug: 120 mg AIC246
Dose regimen 3	Experimental	240 mg AIC246, one tablet per day Receives: Drug: 240 mg AIC246
Placebo	Other	Placebo arm Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With "HCMV Prophylaxis Failure"
Measured: 84 days
Time to Onset of "HCMV Prophylaxis Failure"
Measured: 84 days

Secondary outcomes (1)

Number of Patients With Systemic Detectable HCMV Replication.
Measured: 84 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Dec 2011

First posted5 Feb 2010 (estimated)
Study startMar 2010
Primary completionOct 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HCMV Reactivation or HCMV End-Organ DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01063829
Sponsor's protocol ID: AIC246-01-II-02
Status last verified: Dec 2010
First submitted: 4 Feb 2010
Last updated: 13 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chemaly RF, Ullmann AJ, Stoelben S, Richard MP, Bornhauser M, Groth C, Einsele H, Silverman M, Mullane KM, Brown J, Nowak H, Kolling K, Stobernack HP, Lischka P, Zimmermann H, Rubsamen-Schaeff H, Champlin RE, Ehninger G; AIC246 Study Team. Letermovir for cytomegalovirus prophylaxis in hematopoietic-cell transplantation. N Engl J Med. 2014 May 8;370(19):1781-9. doi: 10.1056/NEJMoa1309533.
PubMed 24806159

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01063829
Acronym / sponsor ID: AIC246-01-II-02
Conditions: HCMV Reactivation or HCMV End-Organ Disease
Keywords: HCMV
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: AiCuris Anti-infective Cures AGIndustry (pharma, biotech, devices)
Collaborators: Quintiles, Inc.
Study start: Mar 2010
Primary completion: Oct 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 5 Feb 2010 (estimated)
Results: Posted 13 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Dose regimen 1	Experimental	Drug: 60 mg AIC24660 mg AIC246, one tablet per day
Dose regimen 2	Experimental	Drug: 120 mg AIC246120 mg AIC246, one tablet per day
Dose regimen 3	Experimental	Drug: 240 mg AIC246240 mg AIC246, one tablet per day
Placebo	Other	Other: PlaceboPlacebo arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
60 mg AIC246Oral administration	Drug	Dose regimen 1
120 mg AIC246Oral administration	Drug	Dose regimen 2
240 mg AIC246Oral administration	Drug	Dose regimen 3
PlaceboOral administration	Other	Placebo

Primary outcome

Number of Participants With "HCMV Prophylaxis Failure"
Time frame: 84 days
Time to Onset of "HCMV Prophylaxis Failure"
Time frame: 84 days

1 secondary outcome

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

Results and safety

Results posted to the registry on 13 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AIC246 (60 mg)	33	17
AIC246 (120 mg)	31	21
AIC246 (240 mg)	34	24
Placebo	33	12

Primary outcome: Number of Participants With "HCMV Prophylaxis Failure"

Time frame: 84 days. Count of participants. Unit: Participants

Measure	AIC246 (60 mg) n = 33	AIC246 (120 mg) n = 31	AIC246 (240 mg) n = 34	Placebo n = 33
Value	16	10	10	21

AIC246 (240 mg) vs Placebo: p = 0.007, Fisher Exact
AIC246 (120 mg) vs Placebo: p = 0.014, Fisher Exact
AIC246 (60 mg) vs Placebo: p = 0.321, Fisher Exact

Primary outcome: Time to Onset of "HCMV Prophylaxis Failure"

Time frame: 84 days. Number. Unit: days

Measure	AIC246 (60 mg) n = 33	AIC246 (120 mg) n = 31	AIC246 (240 mg) n = 34	Placebo n = 33
Value	7	6	2	12

AIC246 (240 mg) vs Placebo: p = 0.002, Log Rank
AIC246 (120 mg) vs Placebo: p = 0.126, Log Rank
AIC246 (60 mg) vs Placebo: p = 0.148, Log Rank

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AIC246 (60 mg)	13 of 33 (39.4%)	31 of 33 (93.9%)	2 of 33
AIC246 (120 mg)	15 of 31 (48.4%)	29 of 31 (93.5%)	1 of 31
AIC246 (240 mg)	12 of 34 (35.3%)	34 of 34 (100%)	1 of 34
Placebo	16 of 33 (48.5%)	33 of 33 (100%)	1 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24806159Chemaly RF, Ullmann AJ, Stoelben S, Richard MP, Bornhauser M, Groth C, Einsele H, Silverman M, Mullane KM, Brown J, Nowak H, Kolling K, Stobernack HP, Lischka P, Zimmermann H, Rubsamen-Schaeff H, Champlin RE, Ehninger G; AIC246 Study Team. Letermovir for cytomegalovirus prophylaxis in hematopoietic-cell transplantation. N Engl J Med. 2014 May 8;370(19):1781-9. doi: 10.1056/NEJMoa1309533.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

24 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 60 mg AIC246, 120 mg AIC246 and 240 mg AIC246 in people with HCMV Reactivation or HCMV End-Organ Disease, run by AiCuris Anti-infective Cures AG at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With "HCMV Prophylaxis Failure" (time frame: 84 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01063829, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.