Sensitive Pulmonary TuberculosisPhase 2NCT04670120

Early Bactericidal Activity Safety Pulmonary Tuberculosis Pyrifazimine (TBI-166)

A Phase 2 study testing Pyrifazimine (TBI-166) in people with Sensitive Pulmonary Tuberculosis, run by Beijing Chest Hospital at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Sensitive Pulmonary Tuberculosis
What is being tested?: Pyrifazimine (TBI-166)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 3 sitesChina
Study dates: 1 Mar 2021to 31 Dec 2021
Phase: Phase 2
Are there results?: None posted in the registry

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

(Those who must meet all the selection criteria can enter the group)
People who volunteer to participate in this trial and sign an informed consent form;
The range of the age is from 18 to 65 years old, regardless of gender;
The weight range of the patient who wear lightweight clothing and no shoes is from 40 to 90 Kg;
The patient is diagnosed with (initial treatment) tuberculosis, and the untreated sputum smear is 2+ or 2 times 1+ or more;
Chest x-ray examination results are consistent with tuberculosis;

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Molecular tests show positive for Mycobacterium tuberculosis (e.g. GeneXpert or Hain) or positive for sputum culture;
Women in the reproductive period have a negative urine pregnancy test and agree to use high-efficiency contraception during the study period;
Male patients must agree to use appropriate contraceptive methods.

Who cannot join

(Meet any of the following criteria will be excluded)
Those who cannot tolerate treatment delay;
Those who have used any drugs that are effective against Mycobacterium tuberculosis within 3 months before screening;
History of allergy to clofazimine, rifamycin and its derivatives, isoniazid, pyrazinamide or ethambutol;
Use any drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes within 30 days before administration (Including but not limited to quinidine, tyramine, ketoconazole, fluconazole, testosterone, quinine, progesterone, Methitione, phenpromazine, doxorubicin, trilithomycin, erythromycin, cocaine, furanilide, cimetidine, dextromethorphan);
Resistance to isoniazid and rifampicin;

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Any disease or symptom that contradicts the use of rifampicin, isoniazid, pyrazinamide or ethambutol;
Severe extrapulmonary tuberculosis (blood disseminated tuberculosis, digestive system tuberculosis, genitourinary tuberculosis, bone and joint tuberculosis, tuberculosis meningitis, etc.);
There is evidence of silicosis, pulmonary fibrosis or other lung diseases considered by researchers to be serious (except tuberculosis);
The patient has chronic obstructive pulmonary disease or asthma;
Any clinically relevant concomitant circumstances or renal impairment characterized by serum creatinine level ≥1.5xULN, or liver damage with ALT and/or AST level ≥3×ULN and/or GGT level ≥3×ULN within the laboratory reference range;
History of alcohol abuse [weekly alcohol intake is greater than 21 units/week (male) and 14 units/week (female) (1 unit=360mL beer; or 150mL glucose wine; or 45mL white wine)], or the subject is unwilling to stop drinking from 24 hours before the start of the study to the end of the study, or had a positive alcohol breath test at the time of enrollment;
Subjects with liver, kidney, metabolism, autoimmune diseases, neurological, mental, blood system diseases, malignant tumors, long-term immunosuppressive agents;
People with a history of drug abuse or a positive urine drug screening;
Screening positive for hepatitis B, HIV, HCV virus and Treponema pallidum antibody;
Those who have a history of fainting needles and are judged to be clinically significant by the investigator;
Participated in clinical research of other drugs or devices three months before the start of the trial;
The subject has the following characteristics at the time of screening (according to the measurement and reading of the central electrocardiogram):
The QT/QTc interval is significantly prolonged, for example, the QTcF (Fridericia correction) or QTcB (Bazett correction) interval is confirmed to be >450 ms during screening;
Has a history of Ventricular tachycardia torsades de pointes, such as heart failure, hypokalemia, long QT syndrome, etc.;
Uses any drug known to extend the QTc interval 30 doses before the medication. (Not limited to amiodarone, bepridil, chloroquine, chlorpromazine, cisapride, cyclobenzaprine, clarithromycin, dipyrazine, doperidol, erythromycin, fluorine alcohol, Haloperidol, ibutilide, levamisole, methadone, mesalamide, pimozine, procaine, quinine, sotalol, sparfloxacin, thiazide);
The investigator judges that any ECG abnormalities of clinical significance.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Beijing Chest Hospital
Beijing, Beijing Municipality, 101149
Shandong Chest Hospital
Jinan, Shandong, 250013
Zhengzhou Sixth People's Hospital
Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With Pyrifazimine (TBI-166)

The new drug pyrifazimine (previous name: TBI-166) developed by the Institute of Materia Medica of the Chinese Academy of Medical Sciences which is Beijing Union Pharmaceutical Second Factory relied on is obtained by retaining the key skeleton of the lead drug clofazimine which can exert its efficacy and modification by introducing moderate polar groups structural. While the drug has strong activity against tuberculosis-sensitive bacteria and drug-resistant bacteria in vivo and in vitro, its pharmacokinetic properties and skin staining side effects have been significantly improved compared with the lead drugs, so that the drug can achieve the goal that reducing fat solubility, accelerating metabolism in the body, reducing skin staining and reducing side effects. In addition, pyrifazimine has a weak effect on liver drug enzymes, and is suitable for combined use in the clinical treatment of tuberculosis. The development of the drug is expected to provide a new method for the clinical treatment of drug-resistant tuberculosis, benefit patients, and produce good social benefits.

In November 2016, the new anti-drug-resistant tuberculosis drug pyrifazimine and its tablets (formerly chemical drug registration classification 1.1) obtained the drug clinical approval issued by the CFDA (batch number: 2016L10025/2016L09987), and were approved the clinical stage research that development of drug-resistant tuberculosis adaptation.

In accordance with relevant requirements of drug registration regulations, technical guidelines, etc., this project has completed the safety, tolerability, and pharmacokinetic clinical trials of a single dose of pyrifazimine tablets in healthy subjects, i.e. Phase Ia clinical trials test.

Conditions: Sensitive Pulmonary Tuberculosis
Being tested: Pyrifazimine (TBI-166)
Keywords: tuberculosis, pyfazimine, early bactericidal activity
Medical subject headings: Tuberculosis

What participants receive

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

Pyrifazimine (TBI-166)Drug
The new drug pyrifazimine (previous name: TBI-166) is obtained by retaining the key skeleton of the lead drug clofazimine which can exert its efficacy and modification by introducing moderate polar groups structural. While the drug has strong activity against tuberculosis-sensitive bacteria and drug-resistant bacteria in vivo and in vitro, its pharmacokinetic properties and skin staining side effects have been significantly improved compared with the lead drugs, so that the drug can achieve the goal that reducing fat solubility, accelerating metabolism in the body, reducing skin staining and reducing side effects.
In November 2016, the new anti-drug-resistant tuberculosis drug pyrifazimine and its tablets obtained the drug clinical approval issued by the CFDA, and were approved the clinical stage research that development of drug-resistant tuberculosis adaptation.

Study groups in NCT04670120
Study group	Role	What they receive
First group	Experimental	Pyfazimine 100mg group, 12 cases. Receives: Drug: Pyrifazimine (TBI-166)
Second group	Experimental	Pyfazimine 200mg group, 12 cases. Receives: Drug: Pyrifazimine (TBI-166)
Third group	Experimental	Pyfazimine 300mg group, 12 cases. Receives: Drug: Pyrifazimine (TBI-166)
Forth group	Active comparator	Pyrazinamide 1500mg group, 10 cases. Receives: Drug: Pyrifazimine (TBI-166)
Fifth group	Active comparator	Pyfazimine 200mg + Pyrazinamide 1500mg group, 10 cases. Receives: Drug: Pyrifazimine (TBI-166)

What is being measured

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

EBA
Early bactericidal activity (EBA), counted by daily log (CFU) change
Measured: The change of TB bacterium burden in sputum from Day 0 to Day 7 and/or Day 14

Timeline

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

1 Mar 202131 Dec 2021

First posted17 Dec 2020
Study start1 Mar 2021
Primary completion30 Jun 2021
Study completion31 Dec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sensitive Pulmonary TuberculosisStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: First group: Pyfazimine 100mg group, 12 cases. Second group: Pyfazimine 200mg group, 12 cases. Third group: Pyfazimine 300mg group, 12 cases. Forth gourp: Pyrazinamide 1500mg group, 10 cases. Fifth group: Pyfazimine 200mg + Pyrazinamide 1500mg group, 10 cases.
Masking: None (open label)
Enrolment: 56 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04670120
Sponsor's protocol ID: GCP-TB-Pyrifazimine (TBI-166)
Status last verified: Sep 2021
First submitted: 7 Dec 2020
Last updated: 20 Sep 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sensitive Pulmonary Tuberculosis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With Pyrifazimine (TBI-166)
ClinicalTrials.gov ID: NCT04670120
Acronym / sponsor ID: GCP-TB-Pyrifazimine (TBI-166)
Conditions: Sensitive Pulmonary Tuberculosis
Keywords: tuberculosis, pyfazimine, early bactericidal activity
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 56 participants (estimated)
Lead sponsor: Beijing Chest HospitalUniversity, hospital or other
Collaborators: Shandong Chest Hospital, The Sixth People's Hospital of Zhengzhou
Study start: 1 Mar 2021 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 31 Dec 2021 (estimated)
First posted: 17 Dec 2020 (actual)
Results: Not posted in the source record

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5
Model description: First group: Pyfazimine 100mg group, 12 cases. Second group: Pyfazimine 200mg group, 12 cases. Third group: Pyfazimine 300mg group, 12 cases. Forth gourp: Pyrazinamide 1500mg group, 10 cases. Fifth group: Pyfazimine 200mg + Pyrazinamide 1500mg group, 10 cases.

Arm	Type	Receives
First group	Experimental	Drug: Pyrifazimine (TBI-166)Pyfazimine 100mg group, 12 cases.
Second group	Experimental	Drug: Pyrifazimine (TBI-166)Pyfazimine 200mg group, 12 cases.
Third group	Experimental	Drug: Pyrifazimine (TBI-166)Pyfazimine 300mg group, 12 cases.
Forth group	Active comparator	Drug: Pyrifazimine (TBI-166)Pyrazinamide 1500mg group, 10 cases.
Fifth group	Active comparator	Drug: Pyrifazimine (TBI-166)Pyfazimine 200mg + Pyrazinamide 1500mg group, 10 cases.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

(Those who must meet all the selection criteria can enter the group)

Key exclusion criteria (23 listed)

(Meet any of the following criteria will be excluded)

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
Pyrifazimine (TBI-166)The new drug pyrifazimine (previous name: TBI-166) is obtained by retaining the key skeleton of the lead drug clofazimine which can exert its efficacy and modification by introducing moderate polar groups structural. While the drug has strong activity against tuberculosis-sensitive bacteria and drug-resistant bacteria in vivo and in vitro, its pharmacokinetic properties and skin staining side effects have been significantly improved compared with the lead drugs, so that the drug can achieve the goal that reducing fat solubility, accelerating metabolism in the body, reducing skin staining and reducing side effects. In November 2016, the new anti-drug-resistant tuberculosis drug pyrifazimine and its tablets obtained the drug clinical approval issued by the CFDA, and were approved the clinical stage research that development of drug-resistant tuberculosis adaptation.	Drug	Fifth group, First group, Forth group, Second group, Third group

Primary outcome

EBA
Time frame: The change of TB bacterium burden in sputum from Day 0 to Day 7 and/or Day 14
Early bactericidal activity (EBA), counted by daily log (CFU) change

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
Individual participant dataSharing planned: No

Related trials for Sensitive Pulmonary Tuberculosis

Not yet recruitingPhase 2
Study of Combinations of Novel Promising Drugs for Pulmonary Tuberculosis
Tuberculosis, Pulmonary
RecruitingPhase 2
Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB
Tuberculosis, Pulmonary
RecruitingPhase 2
Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
Drug Susceptible Pulmonary Tuberculosis
Not yet recruitingObservational study
Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan
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Active, not recruitingPhase 2
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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.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pyrifazimine (TBI-166) in people with Sensitive Pulmonary Tuberculosis, run by Beijing Chest Hospital at 3 sites in China.

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 9 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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?

Results are not available in the source record.

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?

EBA (time frame: The change of TB bacterium burden in sputum from Day 0 to Day 7 and/or Day 14). 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 NCT04670120.

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 20 Sep 2021.