To Evaluate the Long-term Safety and Efficacy of HSK16149 in Chinese Patients With Peripheral Neuralgia

Haisco Pharmaceutical Group

Status and phase: Completed; Phase 3

Conditions: Peripheral Neuropathic Pain

Treatments: Drug: HSK16149 40mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT05890053

HSK16149-303

Details and patient eligibility

About

Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with periphcral neuralgia

Full description

Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with Peripheral neuropathic pain

Enrollment: 301 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who completed double-blind treatment and safety follow-up in HSK16149-201/301.
2. Able to understand and voluntarily sign informed consent.

Exclusion criteria

1. Medication compliance was < 80% in double-blind studies.
2. In double-blind study, EOT visit (V10) eGFR< 60 mL/min//1.73m2
3. Significant safety concerns or adverse events that did not recover before taking the drug in this study arose in the double-blind study.
4. Hepatitis B Surface antigen (HBsAg) positive or hepatitis C virus antibody (HCV Ab) positive during screening [further hepatitis B virus deoxyribonucleic acid (HBV DNA) titer detection or hepatitis C virus ribonucleic acid (HCV RNA) detection (beyond the detection limit of assay need to be excluded)], human immunodeficiency virus antibody (HIV) Ab) positive, serum antibody to treponema pallidum (TP Ab) positive (further test for treponema pallidum titer, if positive, excluded).
5. Women who are pregnant, planning to become pregnant during the study, or breastfeeding; Participants were not expected to use reliable contraceptive methods (including condoms, spermicides, or intrauterine devices) for 28 days after signing up for the ICF or planning to use progester-containing contraceptives during this period.
6. The researcher judged that the study could not be completed according to the scheme or that it was difficult to participate in the study due to safety.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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301 participants in 1 patient group

HSK16149 40mg BID

Experimental group

Description:

HSK16149 40mg , orally twice a day, treatment period; 52-weeks fixed dose.

Treatment:

Drug: HSK16149 40mg BID