A multicentre study to assess the safety and efficacy of sodium hyaluronate (Hyalgan-F) produced by fermentation in knee psteoarthritis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002735-27-LV

Enrollment

120

Registered

2005-09-23

Start date

2005-09-19

Completion date

Unknown

Last updated

2020-06-22

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

Conditions

Knee oasteoarthritis

Interventions

Product Name: Hyalgan-F Product Code: Hyaluronan Pharmaceutical Form: Solution for injection INN or Proposed INN: Hyaluronic acid CAS Number: 6067-32-7 Current Sponsor code: Hyalgan-F Other descriptiv

Eligibility

Inclusion criteria

Inclusion criteria: -Male or female outpatients above 40 years of age, ambulant (only canes are allowed as assistive device), -Suffering from primary knee osteoarthritis (OA) according to ACR diagnostic criteria (i.e., knee pain plus osteophytes + at least one of the following: age above 50 years, crepitus, morning stiffness above 30 minutes in duration) confirmed radiologically, -OA of II-III degree according to Kellgren-Lawrence, -Moderate-severe pain after the 50ft walk on a flat surface (above 40 mm VAS) at baseline, -Discontinuation of analgesic/ NSAID therapy if previously taken prior to baseline, -Willing and able to understand and sign an approved Infromed Consent Form, -No pregnancy, not breast feeding. Females of childbearing potential (including those less than 1 year post-menopausal) must agree to maintain reliable birth control throughout the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the potential immunogenicity of Hyalgan-F (HA-F) a sodium hyaluronate obtained by fermentation and administered by intra-articular (i.a.) route (5 i.a., once a wek for 5 weeks) in a patients with knee osteoarthritis (OA).;Secondary Objective: To evaluate the general safety (AEs. variation in haematological & biochemical parameters) and the efficacy (VAS pain relief and amelioration in the WOMAC Index, patient's and Investigator's overall judgement) of HA-F in the long term after 5 i.a. injections.;Primary end point(s): The study will start with the recruitment of the first patient and will finish with the last visit (month 6) performed on the last patient inserted.	—

Measure

Time frame

Main Objective: To evaluate the potential immunogenicity of Hyalgan-F (HA-F) a sodium hyaluronate obtained by fermentation and administered by intra-articular (i.a.) route (5 i.a., once a wek for 5 weeks) in a patients with knee osteoarthritis (OA).;Secondary Objective: To evaluate the general safety (AEs. variation in haematological & biochemical parameters) and the efficacy (VAS pain relief and amelioration in the WOMAC Index, patient's and Investigator's overall judgement) of HA-F in the long term after 5 i.a. injections.;Primary end point(s): The study will start with the recruitment of the first patient and will finish with the last visit (month 6) performed on the last patient inserted.

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Countries

Latvia

Outcome results

None listed

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