Thymopeptide Enteric-Coated Tablets for idiopathic pulmonary fibrosis patients immunity support treatment

Thymopeptide Enteric-Coated Tablets for idiopathic pulmonary fibrosis patients immunity support treatment, a single center, randomized, controlled clinical study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15005863

Enrollment

Unknown

Registered

2015-01-19

Start date

2015-01-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Treatment group:Oral Thymopeptide Enteric-Coated Tablets 20mg/ days, 3 times / day

no immunotherapeutic group:without immunotherapeutic agent

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed according to the 2011 ATS/ERS/JRS/ALAT for the diagnosis of idiopathic pulmonary fibrosis (IPF); 2. Aged 50-80 years old. Male or female; 3. Good compliance to medicationand timely follow-up examination in accordance with the requirements; 4. Be informed test purpose, method and adverse reaction and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with obvious pulmonary infection (within 4 weeks before screening stage); 2. Patients taking prednisone >15mg/d(or other such dose glucocorticoid) 1 months before entering the group; 3. Patients taking immunomodulators (broncho-vaxom, Pidotimod Granules, thymosin, spleen Aminopeptide immune regulator) 1 months before entering the group; 4. Patients taking immunosuppressants (cyclophosphamide, azathioprine, methotrexate) 1 months before entering the group; 5. Amiodarone users; 6. Patients allergy to Thymosin; 7. Malignant tumor patients; 8. Patients with other system diseases and organ function failure; 9. In the last 3 months participated in other similar drug trials; 10. Pregnancy, breast-feeding women, recent family planning and can not take effective contraceptive measures; 11. Patients with obvious abnormal liver and kidney function: ALT and / or AST > 1.5 times the upper limit of normal; Cr > 1.5 times the upper limit of normal; 12. Patients who the researchers believe not suitable.

Design outcomes

Primary

Measure	Time frame
Hospitalization times of patients due to respiratory system infection and acute exacerbation of idiopathic pulmonary fibrosis;The improvement of the quality of life;	—

Secondary

Measure	Time frame
the change of diffusing capacity of carbon monoxide;The changes of oxygen saturation and walking distance changes in 6 minutes walk test;The changes of high resolution computed tomography;End of treatment of pulmonary fibrosis related events (such as the death toll, the survival function);Changes of immunological indexes in patients with (T cell subgroup classification quantitative, serum complement detection, blood immunoglobulin quantitative);	—

Measure

Time frame

the change of diffusing capacity of carbon monoxide;The changes of oxygen saturation and walking distance changes in 6 minutes walk test;The changes of high resolution computed tomography;End of treatment of pulmonary fibrosis related events (such as the death toll, the survival function);Changes of immunological indexes in patients with (T cell subgroup classification quantitative, serum complement detection, blood immunoglobulin quantitative);

—

Countries

China

Contacts

Public ContactHuiping Li

liw2013@126.com+86 13817389991

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026