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Intense Monitoring Study on Tyvyt

Intense Monitoring Study on Sintilimab Injection (Tyvyt®)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04237233
Enrollment
300
Registered
2020-01-23
Start date
2020-04-02
Completion date
2023-12-31
Last updated
2022-09-16

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

Conditions

Relapsed or Refractory Classical Hodgkin's Lymphoma

Brief summary

The study is a multi-center, prospective, non-interventional and observational study, and will collect data on the safety and efficacy of Tyvyt® in the treatment of Chinese patients with relapsed or refractory classical Hodgkin's lymphoma.

Interventions

None listed

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Patients must be able to understand and voluntarily sign the informed consent form (ICF). Patients must provide reliable contact information, including home phone numbers or follow-up phone number, and be voluntary to be followed up. Patients must have agreed to use Tyvyt® to treat the target indication.

Exclusion criteria

Patients refuse to be included in the study or refuse to cooperate. Patients have participated in another interventional studies within 4 weeks prior to enrollment.

Design outcomes

Primary

MeasureTime frame
Incidence of known adverse drug reactionsDuring the actual Tyvyt treatment time.
Occurrence of new adverse drug reactionsDuring the actual Tyvyt treatment time.
Association, risk factors, severity and incidence of immune-related adverse drug reactions/eventsDuring the actual Tyvyt treatment time.
Association, risk factors, severity and incidence of serious adverse drug reactionsDuring the actual Tyvyt treatment time.
Occurrence of adverse drug reactions in special populationDuring the actual Tyvyt treatment time.

Secondary

MeasureTime frame
Overall survival (OS)During the actual Tyvyt treatment time.

Countries

China

Contacts

Primary ContactLei Zhao
lei.zhao01@innoventbio.com+86 021 31837200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026