Latent Tuberculosis infection (LTBI) MedDRA version: 20.0 Level: PT Classification code 10065048 Term: Latent tuberculosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Rifapentine
Product Name: Rifapentine
Product Code: N/A
Pharmaceutical Form: Tablet
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =16 years to =65 at screening 2. LTBI diagnosis defined on the basis of all of the following: (a) a positive result on an Interferon Gamma Release Assay (IGRA), Tuberculin Skin Test (TST) or C-Tb skin test and (b) negative TB symptoms at screening and (c) no signs of active TB on a Chest X-ray 3. Eligible for LTBI treatment at TB clinics and national LTBI screening services based on NICE guidelines, which means having one or more of the following : • Recent infection (contact tracing); • New entrants at risk (i.e., those that immigrated =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Patients weighing < 30 kg. 2. Need for medications that cannot be safely taken together with study drugs 3. Any medical condition deserving priority of treatment (such as: porphyria, malabsorption syndromes, Clostridium difficile-Associated Diarrhoea and other conditions) 4. History of sensitivity/intolerance to isoniazid or rifamycins 5. Individuals with documented liver disease, defined as: • LFT (ALT/AST/bilirubin) over three times upper limit of normal (ULN) at baseline. This reflects normal clinical practice. For patientparticipant safety, liver function tests are carried on a regular basis. One abnormal value prevents the patient from participating on the study. • Clinical diagnosis of cirrhosis (jaundice, hematemesis, ascites or previous episodes of liver encephalopathy), • HbsAg positive or HCV antibody positive and deemed ineligible for LTBI treatment by the clinician 6. Intending to move outside of the treatment locality within 20 weeks of starting treatment 7. Individuals who would usually be offered LTBI treatment under Directly Observed Therapy (DOT) as part of enhanced case management in complex cases such as those from under-served groups (such as people who are homeless, misuse substances, have been in prison or who are vulnerable migrants). 8. Use of another experimental investigational medicinal product that is likely to interfere with the study medication within 3 months of study enrolment. 9. Women who are breastfeeding, pregnant, or of childbearing potential* who do not agree to use an effective method of contraception from the time consent is signed until 4 weeks after treatment discontinuation or completion. 10. Women of child bearing potential without a negative urine pregnancy test within 7 days prior to being registered for trial treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: There are two primary hypotheses: • The novel short course rifapentine-based regimens 3HP and 1HP improve treatment adherence compared to 3HR • Additional adherence support improves adherence to each treatment regimen compared to routine support ;Secondary Objective: • Proportion of doses missed over the treatment period • Proportion of pills missed over the treatment period • Taking at least 90% of doses and pills over the treatment period • Early study treatment discontinuation for any reason • Permanently stopping study treatment due to drug-related adverse event • Grade =3 adverse events • Adverse events at least possibly associated with study treatment • Development of active TB within 12 months of starting treatment ;Primary end point(s): Adequate treatment adherence, defined as taking = 90% of allotted doses within allowable time-frame specified by regimen;Timepoint(s) of evaluation of this end point: All participants will reach the end of diagnostic follow up 20 weeks after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of doses missed over the treatment period • Proportion of pills missed over the treatment period • Early study treatment discontinuation for any reason • Permanently stopping study treatment due to drug-related adverse event • Grade =3 adverse events • Adverse events associated with study treatment • Development of active TB within 12 months of starting treatment ;Timepoint(s) of evaluation of this end point: The following end points will be evaluated at the end of folllow-up or at the time of event during follow-up period: Proportion of doses missed over the treatment period; Proportion of pills missed over the treatment period; Early study treatment discontinuation for any reason; Permanently stopping study treatment due to drug-related adverse event; Grade =3 adverse events; Adverse events associated with study treatment. For participants who become pregnant during treatment and within one week of their last dose, pregnancy outcomes will be collected using registry data held by NHS Digital and/or Public Health England. Development of active TB within 12 months of starting treatment will be evaluated. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trials Manager
MRC Clinical Trials Unit at UCL
Outcome results
None listed