52 Participants Needed

IV BCV for Adenovirus Infections

(ATHENA Trial)

Recruiting at 13 trial locations
TY
SK
CY
KS
RM
Overseen ByRochelle Maher
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinator or your doctor for guidance.

What data supports the effectiveness of the drug Brincidofovir for treating adenovirus infections?

Research shows that Brincidofovir, a drug related to cidofovir, has been effective in treating severe adenovirus infections in patients with weakened immune systems, such as those who have had organ transplants. It is taken orally and has been shown to reduce the virus in the body without causing kidney damage, which is a common side effect of similar treatments.12345

Is Brincidofovir safe for human use?

Brincidofovir (also known as CMX001) has been used successfully in patients with severe adenovirus infections, including those who are immunocompromised, with reports indicating it is generally safe and well-tolerated. It is noted for having limited toxicity compared to similar treatments and does not cause kidney damage, which is a concern with some other antiviral drugs.12567

How is the drug Brincidofovir different from other treatments for adenovirus infections?

Brincidofovir is unique because it is an oral drug that is a lipid-conjugated form of cidofovir, offering higher levels of the active drug inside cells without the kidney toxicity associated with intravenous cidofovir. It is particularly useful for patients who cannot tolerate other treatments due to kidney issues.12368

What is the purpose of this trial?

The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly (BIW) or 0.4 mg/kg dosed once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV

Eligibility Criteria

This trial is for individuals aged 2 months and older with Adenovirus infection, showing high virus levels in the blood. Participants must either have a widespread infection or be immunocompromised with asymptomatic or localized disease. They should need intravenous treatment but can't join if they have severe skin reactions, gut/liver issues from graft-versus-host disease, weigh over 120 kg, or had recent severe diarrhea.

Inclusion Criteria

AdV DNA viremia >10,000 copies/mL from a single sample, or 2 samples greater than 48 hours apart with the second result higher than the first and both greater than 1000 copies/mL, from the data obtained from the designated central virology laboratory of the local laboratory using the blood sample(s) collected informed consent has been obtained and within 7 days prior to Day 1 (AdV DNA viremia results collected within the 7 day window, but prior to consent may be used if the Informed Consent Form (ICF) signed by the subject provides approval).
Male or female, aged 2 months and older at the time of informed consent.
Either (a) have disseminated AdV disease or (b) have an underlying immunocompromised state, and have asymptomatic AdV infection or localized AdV disease.
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Exclusion Criteria

NIH Stage 4 acute GVHD of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to Day 1.
NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea >556 mL/m2/day for pediatric subjects [or >1000 mL/day for young adults as applicable, at centers in the United States only], or severe abdominal pain with or without ileus) within 7 days prior to Day 1.
Subjects who weigh ≥120 kg.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous Brincidofovir (BCV) at varying doses for 4 weeks

4 weeks
8 visits (in-person) for BIW dosing, 4 visits (in-person) for QW dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 weeks
Weekly monitoring

Treatment Details

Interventions

  • Brincidofovir
Trial Overview The study tests different doses of an intravenous drug called Brincidofovir (BCV) to find a safe and tolerable amount for treating Adenovirus infections. It's given in increasing amounts to see how patients handle it.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: BCV 0.4 mg/kg QWExperimental Treatment1 Intervention
BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
Group II: BCV 0.4 mg/kg BIWExperimental Treatment1 Intervention
BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
Group III: BCV 0.3mg/kg BIWExperimental Treatment1 Intervention
BCV: 0.3 mg/kg administered as a continuous IV infusion over 2 hours
Group IV: BCV 0.2mg/kg BIWExperimental Treatment1 Intervention
BCV: 0.2 mg/kg administered as a continuous IV infusion over 2 hours

Brincidofovir is already approved in United States for the following indications:

🇺🇸
Approved in United States as Tembexa for:
  • Smallpox disease caused by variola virus

Find a Clinic Near You

Who Is Running the Clinical Trial?

SymBio Pharmaceuticals

Lead Sponsor

Trials
24
Recruited
740+
Founded
2005
Headquarters
Tokyo, Japan
Known For
Rare disease research
Top Products
brincidofovir, bendamustine liquid formulation, rigosertib sodium

Findings from Research

Brincidofovir (CMX001) is an effective oral treatment for severe adenoviral pneumonia in renal transplant recipients, especially when intravenous cidofovir causes renal insufficiency.
Brincidofovir has advantages over cidofovir, including better oral bioavailability, no nephrotoxicity, and higher levels of the active drug, making it a safer option for treating adenovirus infections in transplant patients.
Brincidofovir (CMX001) for the Treatment of Severe Adenoviral Pneumonia in Kidney Transplant Recipient.Sudhindra, P., Knoll, B., Nog, R., et al.[2020]
Brincidofovir (BCV) has shown promise as a treatment for disseminated adenovirus infections (d-ADV) in pediatric patients after hematopoietic cell transplant (HCT), which are often fatal and have limited treatment options.
In a report involving four pediatric HCT recipients, all were successfully treated with BCV, indicating its potential efficacy in managing this serious infection.
Rapid Virologic Response to Brincidofovir in Children with Disseminated Adenovirus Infection.Chan, SY., Prockop, SE., Boulad, F., et al.[2021]
Brincidofovir (BCV) demonstrated antiviral activity against adenoviruses in immunocompromised patients, with 67% of subjects on the BCV twice weekly regimen achieving undetectable adenovirus viremia after one week, compared to only 29% in the once weekly group and 33% in the placebo group.
While BCV treatment showed a trend towards lower all-cause mortality compared to placebo, it was associated with a higher incidence of diarrhea and acute graft-versus-host disease, indicating the need for careful monitoring of side effects in patients.
Brincidofovir for Asymptomatic Adenovirus Viremia in Pediatric and Adult Allogeneic Hematopoietic Cell Transplant Recipients: A Randomized Placebo-Controlled Phase II Trial.Grimley, MS., Chemaly, RF., Englund, JA., et al.[2020]

References

Brincidofovir (CMX001) for the Treatment of Severe Adenoviral Pneumonia in Kidney Transplant Recipient. [2020]
Rapid Virologic Response to Brincidofovir in Children with Disseminated Adenovirus Infection. [2021]
Brincidofovir for Asymptomatic Adenovirus Viremia in Pediatric and Adult Allogeneic Hematopoietic Cell Transplant Recipients: A Randomized Placebo-Controlled Phase II Trial. [2020]
New drug on the horizon for treating adenovirus. [2020]
Successful Treatment of Adenovirus Infection with Brincidofovir in an Immunocompromised Patient after Hematological Stem Cell Transplantation. [2020]
Efficacy of Brincidofovir in Pediatric Stem Cell Transplant Recipients With Adenovirus Infections. [2021]
Development of CMX001 (Brincidofovir) for the treatment of serious diseases or conditions caused by dsDNA viruses. [2022]
Brincidofovir as a Salvage Therapy in Controlling Adenoviremia in Pediatric Recipients of Hematopoietic Stem Cell Transplant. [2023]
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