Health Condition 1: D618- Other specified aplastic anemias and other bone marrow failure syndromes Health Condition 2: D561- Beta thalassemia Health Condition 3: D57- Sickle-cell disorders Health Condition 4: B259- Cytomegaloviral disease, unspecified
Conditions
Interventions
Intervention1: Valganciclovir: Valganciclovir (VGCV) treatment will commence on the day of enrollment. The dose will be calculated as 7 body surface area (BSA) creatinine clearance (CrCl) (as per
Sponsors
Sankalp India Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Signed written Informed Consent or Assent. First CMV reactivation following alloHCT. Less than 100 days elapsed since alloHCT. Two CMV reports with greater than 1,000 copies per milliliter or 1 CMV report with Greater than 10,000 copies per milliliter. Males and females at an age between 3 and 18 years. Minimum body weight of 10 kg. Diagnosis of thalassemia, severe aplastic anemia, sickle cell disease or Fanconi s anemia. For women of child bearing potential: a negative pregnancy test.
Exclusion criteria
Exclusion criteria: Life-threatening CMV infection defined by: DNAemia with greater than 100,000 copies per millilitre or Clinically suspected CMV pneumonitis Liver blood tests suggestive of CMV hepatitis such as Alanine aminotransferase greater than 3 times upper limit of norm and Aspartate aminotransferase or Alanine aminotransferase ratio less than 1 within one week prior to enrolment. Watery diarrhea: greater than or equal to 3 stools per day and abdominal cramps as clinical signs suggestive of CMV enterocolitis within 48 hours prior to enrolment. Acute gut GVHD organ grade two to four. Neutrophil count less than 500 million cells per liter Patients with watery diarrhea greater than or equal to 3 stools per day and abdominal cramps, or bloody diarrhea for any reason within 48 hours prior to enrolment. History of significant adverse reaction to GCV, VGCV, aciclovir or valacyclovir. Clinically or molecularly proven GCV resistance. Treatment with an investigational drug within the last 28 days. Creatinine clearance less than 60 mL per minute per 1.73 meter square as calculated with the modified Schwartz formula. Need for intensive care. Inability to take oral drugs. Simultaneous participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is confirmed clearance of CMV viremia (assessed by PCR) three weeks after start of VGCV treatment.Timepoint: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be addressed in all populations: Rate of neutropenia & thrombocytopenia, VGCV pharmacokinetics, CMV clearance & rate of recurrent CMV reactivation.Timepoint: Efficacy of oral valganciclovir will be tested on day 5 or 6 after administration of medication. Rate of neutropenia at week 3. Thrombocytopenia will be checked at week 3. Rate of CMV recurrence at week 12 after trial start for each subject. | — |
Countries
India
Contacts
Public ContactRajat Kumar Agarwal
Sankalp India Foundation
Outcome results
None listed