A Phase 2 interventional study of Standard of Care and Brincidofovir in Adenovirus, sponsored by Chimerix. Terminated at 36 sites in 9 countries. Open to participants aged 2 Months to 25 Years. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by Chimerix (part of Jazz Pharmaceuticals) · Phase 2, Interventional, and Treatment
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Among 78 studies in Adenoviridae Infections with a site in United States — 17 open to participants now, 21 under way, 2 of them phase 3. Adenoviridae Infections · United States.
Among the 78 studies in Adenoviridae Infections with a site in United States, this one is the 32nd largest by enrollment of the 68 interventional ones that give a count, is one of 5 that started in 2017, is one of 13 in phase 2, and was the 52nd registered.
136 studies on the registry are indexed under Adenoviridae Infections; 34 are open to participants now.
Browse Adenoviridae Infections studies →17 of the 78 studies in Adenoviridae Infections with a site in United States are open now. Recruiting first, the newest first:
New York Medical College · Sites in United States
Ages 1 days–30 yrs
Dispatch Biotherapeutics · Sites in United States
Ages 18+
SymBio Pharmaceuticals · Sites in United States, Austria, Belgium and 10 more countries
Ages 2 mo+
Jessie L. Alexander · Sites in United States
Ages 1 mo–65 yrs
Monica Bhatia · Sites in United States
Ages 3 mo–26 yrs
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Adenoviridae Infections studies recruiting now, 9 (36%) set no upper age limit and 12 (48%) stop at 75 or younger; 17 take children under 18; 4 take healthy volunteers.
This study: 2 Months to 25 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
78 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 43 · Phase 2 30 · Phase 3 9 · Phase 4 1
First in 2002; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 29 is close to the median of 30 across 109 interventional studies indexed under Adenoviridae Infections.
Median enrollment 27 across the 68 interventional studies, 436 across the 8 observational. Of the 46 that completed or were terminated, 18 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 78 have an industry lead sponsor. The 10 most frequent:
This study is registered under Chimerix, one of the names counted as Jazz Pharmaceuticals. Under that name alone:
Chimerix is the lead sponsor of 33 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Jazz Pharmaceuticals has 6 studies filed under Adenoviridae Infections — fewer than ten, so there is no comparison to draw.
6 of the studies in Adenoviridae Infections with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04673942EpicentRx, Inc.A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors | 2026-12-01 |
| NCT03266627New York Medical CollegeAdenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection | 2026-12-31 |
| NCT02048332Children's Hospital Medical Center, CincinnatiDonor-Derived Viral Specific T-cells (VSTs) | 2027-01 |
| NCT05271318TILT Biotherapeutics Ltd.Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer. | 2027-03 |
| NCT03665675Sumithira VasuDonor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT | 2027-03-20 |
Add all 6 to your calendar (.ics) → With an account.
Among the 78 studies in Adenoviridae Infections with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study was designed to assess the safety, overall tolerability, and antiviral activity of "short course" brincidofovir (BCV) therapy, as compared with current standard of care (SoC), for the treatment of adenovirus (AdV) infections in high-risk (i.e., T cell depleted) pediatric allogeneic hematopoietic cell transplant (HCT) recipients. A virologic response-driven approach to the duration of treatment was to be evaluated, in which subjects randomized to BCV therapy were to be treated until AdV viremia was confirmed as undetectable or until a maximum of 16 weeks of therapy, whichever occurred first. The formulation of BCV used in this study was oral tablet/suspension.
This was a randomized, open-label, multi-center study of the safety, overall tolerability, and antiviral activity of BCV, as compared with SoC, in pediatric (and young adults in the United States) recipients of high-risk (i.e., T cell-depleted and/or unrelated cord blood graft, or a T cell-replete graft from ahaploidentical donor with post-transplant cyclophosphamide administration) allogeneic HCT. Subjects with AdV detected in plasma after their qualifying transplant could be screened for participation in the study. Subjects who met all applicable entry criteria were randomized in a 2:1 ratio to receive either BCV or SoC (i.e., investigator-assigned therapy). The formulation of BCV used in this study was oral tablet/suspension. Subjects were randomized within 100 days post-transplant; for study purposes, the day of randomization was defined as Day 1. During randomization, subjects were stratified based on the following variables: last AdV viremia (≥10,000 copies/mL versus \<10,000 copies/mL) measurement available from the designated central virology laboratory prior to randomization, time from transplant to randomization (≥28 days versus \<28 days), and T cell-depletion methodology (receipt of alemtuzumab or ex vivo depletion versus receipt of anti-thymocyte globulin [ATG] or no T cell depletion).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects were high-risk hematopoietic cell transplant (HCT) recipients aged 2 months to \<18 years (\<26 years in the United States) who met adenovirus (AdV) viremia criteria within 7 days of randomization (Day 1), and all other eligibility criteria. High-risk was defined as having received 1 of the following:
A T cell-depleted graft:
Subjects must have had qualifying AdV viremia within 100 days of transplant, which was defined as having either:
Written (and assent, where applicable) to participate in the study was obtained from each subject and his/her legal guardian(s) in accordance with national or local law and institutional practice.
Exclusion Criteria:
When applicable, female subjects of (i.e., not pre-menarche) were not pregnant or breastfeeding, and if sexually active, agreed to use 2 acceptable forms of , 1 of which must have been a barrier method and the other a highly-effective method of contraception. Male subjects, if sexually active and capable of fathering a child, agreed to use a barrier method of contraception while enrolled in the study and for at least 90 days after the last dose of BCV.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brincidofovir (BCV) for the treatment of adenovirs (AdV) infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients. Brincidofovir (BCV) treatment began no later than 100 days post-transplant and was to continue for a maximum of 16 weeks. Brincidofovir (BCV) was discontinued once AdV viremia was confirmed undetectable. Subjects who did NOT receive concurrent cyclosporine on Day 1: * If ≥48kg body weight, one 100mg oral tablet BIW (or 10mL of 10mg/mL oral suspension if unable to take tablets). * If \<48kg body weight, 2mg/kg oral volume of 10mg/mL oral suspension BIW. Subjects who received cyclosporine on Day 1 (or initiated cyclosporine at any time): * 1.4mg/kg (maximum of 70mg) oral volume of 10mg/mL oral suspension BIW. * 2mg/kg (maximum of 100mg) oral volume of 10mg/mL oral suspension BIW if discontinued cyclosporine.
Drug: Brincidofovir
Local institutional standard of care (SoC) (i.e., investigator-assigned therapy) for the treatment of adenovirus infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients. Management of these subjects was prescribed by the investigator as being in the best interests of the subject and may have included a "watch-and-wait" approach, with or without decreased immunosuppression (ergo, no treatment), or treatment administration with other available antivirals, most commonly cidofovir intravenously. Decisions regarding SoC, including administration of therapy, dose and regimen of therapy, modification of immunosuppression, and monitoring was the responsibility of the clinical team caring for the subject, according to institutional guidelines, local practices, and applicable guidelines for the management of AdV infection.
Other: Standard of Care
Local institutional standard of care (SoC) (i.e., investigator-assigned therapy) for the treatment of adenovirus infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.
Also known as: SoC
Brincidofovir (BCV) for the treatment of adenovirus infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.
Also known as: BCV
Time-averaged Area Under the Concentration-time Curve for Plasma Adenovirus Viremia (Log10 Copies/mL).
The primary efficacy endpoint for this study was the time-averaged area under the concentration-time curve for plasma adenovirus (AdV) viremia (log10 copies/mL) from randomization through Week 16 post-randomization. Due to the small number of subjects enrolled in the study, formal efficacy analyses were not performed. Individual subject AdV viremia profiles show the differential anti-adenoviral effect of brincidofovir (BCV) in comparison to standard of care (SoC) therapy.
Time frame: From randomization to 16 weeks post-randomization
| Milestone | Brincidofovir | Standard of Care |
|---|---|---|
| Started | 20 | 9 |
| Completed | 11 | 5 |
| Not completed | 9 | 4 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Study terminated | 4 | 3 |
| Withdrew: Investigator decision | 1 | 0 |
The primary efficacy endpoint for this study was the time-averaged area under the concentration-time curve for plasma adenovirus (AdV) viremia (log10 copies/mL) from randomization through Week 16 post-randomization. Due to the small number of subjects enrolled in the study, formal efficacy analyses were not performed. Individual subject AdV viremia profiles show the differential anti-adenoviral effect of brincidofovir (BCV) in comparison to standard of care (SoC) therapy.
No measurements were reported for this outcome.
Collected over From randomization to 16 weeks post-randomization.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brincidofovir | 4/20 (20%) | 15/20 (75%) | 20/20 (100%) |
| Standard of Care | 1/9 (11.1%) | 6/9 (66.7%) | 9/9 (100%) |
| Event | Brincidofovir | Standard of Care |
|---|---|---|
| PyrexiaGeneral disorders | 1/20 | 3/9 |
| Evans SyndromeBlood and lymphatic system disorders | 0/20 | 1/9 |
| DiarrhoeaGastrointestinal disorders | 0/20 | 1/9 |
| Enterococcal bacteraemiaInfections and infestations | 0/20 | 1/9 |
| Gastroenteritis viralInfections and infestations | 0/20 | 1/9 |
| Human herpesvirus 6 infectionInfections and infestations | 0/20 | 1/9 |
| Lower respiratory tract infection fungalInfections and infestations | 0/20 | 1/9 |
| Pneumonia cytomegaloviralInfections and infestations | 0/20 | 1/9 |
| Flank painMusculoskeletal and connective tissue disorders | 0/20 | 1/9 |
| Acute kidney injuryRenal and urinary disorders | 1/20 | 1/9 |
| Event | Brincidofovir | Standard of Care |
|---|---|---|
| PyrexiaGeneral disorders | 8/20 | 5/9 |
| DiarrhoeaGastrointestinal disorders | 7/20 | 1/9 |
| Abdominal painGastrointestinal disorders | 6/20 | 1/9 |
| VomitingGastrointestinal disorders | 6/20 | 1/9 |
| NeutropeniaBlood and lymphatic system disorders | 2/20 | 2/9 |
| Graft versus host diseaseImmune system disorders | 0/20 | 2/9 |
| Graft versus host disease in skinImmune system disorders | 2/20 | 2/9 |
| RhinitisInfections and infestations | 0/20 | 2/9 |
| Alanine aminotransferase increasedInvestigations | 2/20 | 2/9 |
| Gamma-glutamyltranferase increasedInvestigations | 4/20 | 2/9 |
Due to the premature termination of this study, statistical analyses were not performed. Limited demographic, efficacy, and safety data are provided for the 29 subjects who were enrolled as descriptive summaries.
| Age, Categorical(Participants) | Brincidofovir | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 20 | 9 | 29 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Brincidofovir | Standard of Care | Total |
|---|---|---|---|
| Mean | 5.1 ± 4.05 | 5.9 ± 4.18 | 5.3 ± 4.04 |
| Sex: Female, Male(Participants) | Brincidofovir | Standard of Care | Total |
|---|---|---|---|
| Female | 8 | 5 | 13 |
| Male | 12 | 4 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Brincidofovir | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 18 | 8 | 26 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Brincidofovir | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 0 | 0 | 0 |
| White | 17 | 4 | 21 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 4 | 5 |
| Region of Enrollment(participants) | Brincidofovir | Standard of Care | Total |
|---|---|---|---|
| United States | 4 | 2 | 6 |
| United Kingdom | 12 | 5 | 17 |
| Italy | 0 | 1 | 1 |
| France | 3 | 0 | 3 |
| Germany | 1 | 1 | 2 |
| Adenovirus in plasma(Participants) | Brincidofovir | Standard of Care | Total |
|---|---|---|---|
| Count of participants | 20 | 9 | 29 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in May 2019, 16 months.
Results were first posted in Jan 2021, 1 year 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Brincidofovir